NC TREK 1012451-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 08717648151965), received between Aug 3, 2016 and Jul 22, 2024 — classified as 3 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (22 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2024Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THE PATIENT UNDERWENT STENT IMPLANTATION DUE TO CORONARY HEART DISEASE. TWO NON-ABBOTT STENTS (3.5X29MM AND 3.5X8MM) WERE IMPLANTED, BALLOON DILATION WAS TO BE PERFORMED WITH THE 3.5X8MM TREK BALLOON DILATATION CATHETER (BDC). HOWEVER, DURING ADVANCEMENT RESISTANCE WAS FELT AND THE TIP OF THE TREK BDC SEPARATED INSIDE THE GUIDE CATHETER. THE SEPARATED TIP AND GUIDE CATHETER WERE REMOVED TOGETHER, BY HAND. A NEW TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794995 ↗
• MalfunctionNov 2, 2023Deflation Problem; No Apparent Adverse Event; Deflation Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. THE 3.5X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED BUT COULD NOT BE FULLY DEFLATED. THE BALLOON WAS WITHDRAWN PARTIALLY DEFLATED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS REPORTED THAT THE DEVICE THAT FAILED TO DEFLATE WAS A NON-ABBOTT BALLOON. THERE WAS NO ISSUE WITH THE NC TREK BDC. THERE IS NO COMPLAINT AGAINST THE NC TREK BDC. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18056841 ↗
• MalfunctionJun 5, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. AFTER PRE-DILATED OF THE LESION A NON-ABBOTT STENT WAS IMPLANTED. THE 3.50X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR POST-DILATATION AND DIFFICULTY WAS NOTED DUE TO THE ANATOMY. THE BALLOON WAS WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATM) AFTER 10 SECONDS. THEREFORE, THE BDC WAS REMOVED FROM THE ANATOMY. A NON-ABBOTT BALLOON WAS USED FOR POST-DILATATION IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17063553 ↗
• MalfunctionOct 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY THAT IS 75% STENOSED. A 3.5X12MM XIENCE SKYPOINT WAS DEPLOYED AND A 3.5X8MM NC TREK WAS ATTEMPTED TO POST-DILATE; HOWEVER, A PINHOLE RUPTURE WAS NOTED DURING THE FIRST INFLATION AT 10 ATMOSPHERES. A NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670460 ↗
• MalfunctionJun 10, 2022Difficult to Insert; Material Separation; Difficult to Insert; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED ARTERY. THE 3.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE INSERTED IN THE GUIDE CATHETER WHEN THE BALLOON CATHETER SNAPPED APART [SEPARATED]. IT WAS NOTED THAT IT WAS THE PROXIMAL (8-10 INCHES FROM THE TIP OF THE HUB) PART OF THE BDC THAT SEPARATED AND SEPARATED IN 2 PIECES OUTSIDE OF THE ANATOMY. THE BDC WAS SIMPLY WITHDRAWN. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14657432 ↗
• MalfunctionMar 26, 2022Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS DE NOVO MID LEFT ANTERIOR DESCENDING ARTERY. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED AND A NON-ABBOTT BALLOON WAS USED FOR PRE-DILATATION. A 3.0X23MM XIENCE SKYPOINT WAS DEPLOYED AND A 3.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED FOR POST-DILATATION; HOWEVER, THE BDC RUPTURED AT 8 ATMOSPHERES DURING THE FIRST INFLATION. RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE NC TREK. ANOTHER NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13922951 ↗
• InjuryJan 21, 2022Material Rupture; Failure to Deflate; Material Rupture; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTALLY OCCLUDED LESION IN AN UNSPECIFIED ARTERY. THE 3.5X8MM AND 3.5X15MM NC TREK BALLOON DILATATION CATHETERS (BDC) WERE INFLATED ONCE UP TO 10 ATMOSPHERES (ATMS) AND NEGATIVE WAS HELD FOR 5 SECONDS TO DEFLATE THE BALLOONS, HOWEVER, THE BALLOONS COULD NOT BE DEFLATED. THERE WAS NO DIFFICULTY REMOVING THE STYLET OR PROTECTIVE SHEATH AND THE DEVICES WERE PREPARED (AIR ASPIRATION) OUTSIDE THE ANATOMY PRIOR TO USE. CONTRAST MIX USED WAS PER INSTRUCTIONS FOR USE. THE DEVICES WERE WITHDRAWN FULLY INFLATED. THE PATIENT HAD NO FLOW IN THE ARTERY AND HYPOTENSION OCCURRED. ADENOSINE WAS ADMINISTERED INTRAVENOUSLY AND ANOTHER BALLOON WAS USED FOR POST DILATATION. VASOVAGAL SYNCOPE ALSO OCCURRED THAT NEEDED TIME TO TREAT AND RECOVER WHICH CAUSED A DELAY IN THE PROCEDURE. THE PATIENT IMPROVED AND THERE WAS NO PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Syncope/Fainting

  MAUDE report 13315462 ↗
• MalfunctionNov 22, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS RIGHT CORONARY ARTERY THAT IS 99% STENOSED. THE 3.5X8MM NC TREK BALLOON DILATATION CATHETER WAS ATTEMPTED TO PRE-DILATE THE LESION; HOWEVER, RUPTURED DURING THE SECOND INFLATION AT 12 ATMOSPHERES. ANOTHER SAME SIZE NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PRE-DILATATION AND AN UNSPECIFIED STENT WAS IMPLANTED. POST-DILATATION WAS PERFORMED WITH AN UNKNOWN BALLOON. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED; HOWEVER, A CLINICALLY SIGNIFICANT DELAY WAS NOTED. SUBSEQUENT TO THE INITIAL REPORT BEING FILED IT WAS REPORTED THAT THE DELAY DID NOT CAUSE AN ADVERSE PATIENT EFFECT ON THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852372 ↗
• MalfunctionNov 8, 2021Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 3.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE USED; HOWEVER, THE BALLOON RUPTURED AT 20 ATMOSPHERES DURING THE THIRD INFLATION. ADDITIONALLY, IT WAS NOTED THE BDC WAS NOT SOAKED PRIOR TO USE. ANOTHER SAME SIZE NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770656 ↗
• MalfunctionNov 1, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS, 99% STENOSED LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER A NON-ABBOTT STENT WAS DEPLOYED, A 3X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 12 ATMOSPHERES. A SAME SIZED NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729097 ↗
• MalfunctionSep 23, 2021Difficult to Remove; Failure to Advance; Difficult to Advance; Difficult to Remove; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THIS WAS A PROCEDURE TO TREAT A HEAVILY CALCIFIED AND HEAVILY TORTUOUS CORONARY ARTERY. AN NC TREK 3.50X8MM BALLOON DELIVERY CATHETER (BDC) WAS INSERTED, BUT DUE TO THE HEAVY CALCIFICATION, THE DEVICE WAS UNABLE TO CROSS THE LESION. IT WAS NOTED THAT RESISTANCE WAS FELT DURING ADVANCEMENT AND REMOVAL OF THE DEVICE. A 3.50X15MM BDC WAS THEN INSERTED. HOWEVER, THIS DEVICE WAS ALSO UNABLE TO CROSS THE LESION. RESISTANCE WAS AGAIN FELT DURING ADVANCEMENT AND REMOVAL. A NON-ABBOTT DEVICE WAS THEN USED TO PERFORM THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518854 ↗
• MalfunctionAug 9, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PREPARATION OF A 3.5X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) THE STYLET WAS REMOVED; HOWEVER, MORE RESISTANCE WAS NOTED THAN USUAL. THE BDC WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THE PATIENTS VITALS CHANGED SUDDENLY AND THE PROCEDURE WAS CANCELED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297445 ↗
• MalfunctionMay 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MODERATELY CALCIFIED, 90% STENOSED RIGHT CORONARY ARTERY. A 3.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE, AND THE BALLOON RUPTURED DURING THE FIRST INFLATION BELOW RATED BURST PRESSURE. THE BDC WAS REMOVED WITHOUT RESISTANCE, AND A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890542 ↗
• MalfunctionApr 28, 2021Failure to Fold; Difficult to Remove; Failure to Fold; Difficult to Remove

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740004 ↗
• MalfunctionMar 9, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. A 3.5X8MM NC TREK RX BALLOON RUPTURED DURING FIRST INFLATION AT NOMINAL PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED NC TREK BALLOON FOR POST-DILATATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11449283 ↗
• MalfunctionFeb 2, 2021Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 3.5X8MM NC TREK BALLOON WAS ADVANCED TO THE LESION FOR PRE-DILATATION. WHEN INFLATED, AT AN UNSPECIFIED PRESSURE (AS PRESSURE WENT UP) THE BALLOON FAILED TO INFLATE. ANGIOGRAM SHOWED THAT THE CONTRAST WAS COMING OUT FROM THE BALLOON ITSELF. ANOTHER NC TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11269394 ↗
• MalfunctionNov 26, 2020Inflation Problem; Material Rupture; Difficult to Advance; Inflation Problem; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE FIRST MARGINAL ARTERY. A 3.5X8MM NC TREK WAS ABLE TO BE ADVANCED TO THE LESION, HOWEVER WITH SOME RESISTANCE MET WITH THE ANATOMY. ONCE AT THE LESION AND PRESSURIZED ONCE AT 4 ATMOSPHERES, THE BALLOON COMPLETELY FAILED TO INFLATE DUE TO THE BALLOON RUPTURING. THE LEAK WAS NOTED COMING FROM THE BALLOON ITSELF. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NON-ABBOTT BALLOON AND GUIDELINER WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10909082 ↗
• MalfunctionSep 29, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION WITH MODERATE CALCIFICATION, HEAVY TORTUOSITY, AND 90% STENOSIS IN THE MID-RIGHT CORONARY ARTERY. A 3.5 X 8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO PERFORM POST-DILATATION; HOWEVER, RESISTANCE WAS MET INSIDE AN UNSPECIFIED STENT DURING ADVANCEMENT AND THE BALLOON RUPTURED ON THE THIRD INFLATION AT 12 ATMOSPHERES. THE BDC WAS REMOVED FROM THE PATIENT¿S ANATOMY AND THERE WERE NO ISSUES CONFIRMED BY IVUS. THE PROCEDURE ENDED AT THIS POINT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10603332 ↗
• InjuryMar 5, 2020Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. AN NC TREK 3.50X8MM BALLOON DILATATION CATHETER (BDC) WAS USED IN THE ANATOMY, BUT THE PHYSICIAN NOTED THAT THE BALLOON FAILED TO DEFLATE ON THE INITIAL ATTEMPT. AFTER MULTIPLE ATTEMPTS, THE BALLOON SUCCESSFULLY DEFLATED AND WAS REMOVED FROM THE ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793955 ↗
• MalfunctionFeb 18, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE HEAVILY TORTUOUS, HEAVILY CALCIFIED, 90% STENOSED LEFT MAIN CORONARY ARTERY. A 3.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) FACED RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT BUT REACHED THE LESION, AND THE BALLOON WAS INFLATED TO 12 ATMOSPHERES (ATMS). THE BALLOON WAS INFLATED AGAIN TO 9 ATMS WHEN THE BALLOON RUPTURED. THE BDC WAS REMOVED WITHOUT RESISTANCE, AND A NON-ABBOTT BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9720088 ↗
• MalfunctionDec 19, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT AN UNSPECIFIED LESION. TWO 3.50X8MM RX NC TREK BALLOON DILATATION CATHETERS AND A SIMILAR UNSPECIFIED BALLOON WERE ADVANCED TO THE LESION. DURING REMOVAL, THE SHAFT SEPARATED INSIDE THE GUIDING CATHETER. THE SEPARATED DISTAL SHAFT AND THE GUIDING CATHETER WERE REMOVED AS A SINGLE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9499645 ↗
• MalfunctionDec 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 3.5 X 8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION, WHEN INFLATING TO 8 ATMOSPHERES, THE BALLOON RUPTURED. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9462671 ↗
• MalfunctionNov 11, 2019Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED VESSEL. THE 3.5X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INSERTED BUT NOT USED AND REMOVED. THE BDC WAS RE-INSERTED AND INFLATED ONCE; HOWEVER, THE BALLOON COULD NOT BE FULLY DEFLATED. THE BDC WAS ABLE TO BE REMOVED WITHOUT ISSUE. ANOTHER BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9307552 ↗
• MalfunctionOct 15, 2019Inflation Problem; Stretched; Inflation Problem; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 3.5X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) COMPLETELY FAILED TO INFLATE INSIDE THE ANATOMY BUT OUTSIDE THE ANATOMY WAS ABLE TO BE INFLATED WITH NO ISSUES. A NEW, SAME SIZE NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS IDENTIFIED A STRETCHED SHAFT JUST PROXIMAL TO THE BALLOON SEAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192932 ↗
• MalfunctionSep 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AIR ASPIRATION, A 3.5X8MM NC TREK BALLOON DILATATION CATHETER WAS NOTED TO HAVE A LOT OF AIR, SO THE BALLOON WAS INFLATED AND A RUPTURE WAS NOTED OUTSIDE THE ANATOMY. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9090436 ↗