NC TREK 1012448-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08717648151804), received between Sep 28, 2016 and Mar 31, 2025 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2025Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method; Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2025, TO TREAT A LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 99% STENOSED. THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. A 2.75X8MM NC TREK BALLOON WAS NOT PREPPED OUTSIDE THE ANATOMY PRIOR TO USE. THE NC TREK BALLOON WAS USED FOR PRE-DILATATION BUT THE BALLOON COMPLETELY FAILED TO INFLATE UNDER PRESSURE AFTER ONE INFLATION. THE NC TREK BALLOON WAS WITHDRAWN AND A LEAK WAS NOTED. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. ON (B)(6) 2025, THE PATIENT RETURNED TO THE WARD AND DIED FOR UNKNOWN REASONS; HOWEVER, IN THE PHYSICIAN'S OPINION THE NC TREK BALLOON DID NOT CAUSE OR CONTRIBUTE TO PATIENT'S DEATH. SUBSEQUENTLY, RETURNED DEVICE ANALYSIS OBSERVED THAT A LEAK OR RUPTURE WAS NOT VISIBLE HOWEVER, A LEAK WAS NOTED AT THE GUIDEWIRE NOTCH WHEN ATTEMPTING TO INFLATE THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21733214 ↗
• MalfunctionFeb 22, 2024Inflation Problem; Difficult to Remove; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE PROTECTIVE SHEATH OF THE 2.75X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS REMOVED WITH DIFFICULTY. AFTER PRE-DILATATION AND IMPLANTATION OF A NON-ABBOTT STENT, THE NC TREK BDC WAS ADVANCED FOR POST-DILATATION; HOWEVER, THE BALLOON FAILED TO INFLATE. SEVERAL ATTEMPTS WERE MADE TO INFLATE THE BALLOON AND THE INFLATION DEVICE WAS REPLACED; HOWEVER, THE BALLOON STILL DID NOT INFLATE. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND ANOTHER SAME SIZE NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANTLY DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18760398 ↗
• MalfunctionOct 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS PROXIMAL AND MIDDLE SEGMENT OF THE ANTERIOR DESCENDING ARTERY. AN UNSPECIFIED STENT WAS IMPLANTED AND POST DILATATION WAS GOING TO BE PERFORMED WITH THE 2.75X8 MM NC TREK BALLOON DILATATION CATHETER (BDC). WHEN THE DEVICE WAS OPENED, IT WAS NOTED THAT THE SHAFT OF THE DEVICE WAS SEPARATED. A NEW SAME SIZE NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT INVOLVEMENT 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 17913800 ↗
• MalfunctionJun 28, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING OPENING OF THE PACKAGE OF A 2.75X8MM NC TREK BALLOON DILATATION CATHETER (BDC), THE OUTER PACKAGE LABELING WAS NOTED TO BE INCONSISTENT WITH THE POUCH LABELING. ANOTHER SAME SIZE NC TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17220692 ↗
• MalfunctionMar 11, 2021Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance; Material Separation; Improper or Incorrect Procedure or Method; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DE NOVO LESION IN THE MODERATELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER AN UNSPECIFIED STENT WAS IMPLANTED, A 3X8MM NC TREK BALLOON DILATATION CATHETER (BDC) FAILED TO CROSS THE LESION DUE TO THE ANATOMY, AND THE PROXIMAL SHAFT SEPARATED INTO TWO PIECES. THE BDC WAS SIMPLY WITHDRAWN WITHOUT RESISTANCE. A 2.75X8MM NC TREK BDC ALSO FAILED TO CROSS THE LESION DUE TO THE ANATOMY, AND THE PROXIMAL SHAFT SEPARATED INTO TWO PIECES. THE BDC WAS SIMPLY WITHDRAWN WITHOUT RESISTANCE. THEN A 2.5X8MM NC TREK BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: DURING PREP, THE 2.75X8MM NC TREK BALLOON WAS SLIGHTLY INFLATED TO CHECK FOR ANY LEAK. A TEAR IN THE GUIDE WIRE EXIT NOTCH OF THE 3X8MM NC TREK BALLOON WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463230 ↗
• MalfunctionMar 7, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY THAT WAS BOTH MODERATELY TORTUOUS AND CALCIFIED. AN NC TREK RX 2.75 X 8MM WAS ATTEMPTED TO BE DELIVERED TO THE LESION BUT FAILED TO CROSS. RESISTANCE WAS NOTED DURING REMOVAL. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER BALLOON WAS USED TO PERFORM PRE-DILATATION AND THE PROCEDURE CONTINUED. NO ADDITIONAL REQUESTS FOR INFORMATION ARE NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 11427357 ↗
• MalfunctionJul 23, 2020Inflation Problem; Leak/Splash; Material Split, Cut or Torn; Inflation Problem; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE 2.75X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE TO TREAT THE RIGHT CORONARY ARTERY, BUT THE BDC WAS UNABLE TO INFLATE. THE INFLATION DEVICE WAS REPLACED AND ANOTHER ATTEMPT TO INFLATE THE SAME BDC WAS MADE, BUT THE BDC WOULD STILL NOT INFLATE. THERE WAS NO CONTRAST GOING INTO THE BDC. THE CUSTOMER SUSPECTS THAT THE BDC WAS DAMAGED BEFORE IT WAS INSERTED INTO THE PATIENT. ANOTHER BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DEVICE ANALYSIS FOUND A TEAR AND LEAK ON THE RETURNED DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314149 ↗
• MalfunctionNov 6, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. DURING THE BEGINNING OF THE PROCEDURE, AFTER A 2.75X8MM NC TREK WAS BACKLOADED OVER THE GUIDE WIRE, IT WAS NOTED THAT THE HUB OF THE BALLOON BECAME SEPARATED FROM THE PROXIMAL SHAFT. 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: No Consequences Or Impact To Patient

  MAUDE report 9286752 ↗
• InjuryOct 21, 2019Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A DENOVO LESION IN THE CIRCUMFLUX ARTERY. A .2.75 X 08 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION. THE BALLOON WAS INFLATED TO PERFORM PRE-DILATATION; HOWEVER, THE BALLOON COULD NOT BE DEFLATED AFTER THE SECOND INFLATION. THERE WAS RESISTANCE REMOVING THE BDC; AND THEREFORE, ASPIRATIONS WAS PERFORMED AND THE BDC WAS ABLE TO BE REMOVED. THE PROCEDURE CONTINUED AND A 2.75 X 18 MM XIENCE STENT WAS ABLE TO BE DEPLOYED THROUGH DIRECT STENTING TO SUCCESSFULLY TREAT THE TARGET LESION. 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 9214703 ↗
• MalfunctionOct 23, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PREPARATION AND BEFORE USE, THE PROTECTIVE SHEATH OF THE NC TREK 2.75 X 8 MM BALLOON DILATATION CATHETER WAS DIFFICULT TO REMOVE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7997522 ↗
• MalfunctionAug 15, 2018Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THAT RESISTANCE WAS MET DURING REMOVAL OF THE PROTECTIVE SHEATH. NEXT, THE DEVICE WAS SOAKED IN A SALINE SOLUTION. DURING THE PROCEDURE OF THE MODERATELY TORTUOUS, NON-CALCIFIED, MID RIGHT CORONARY ARTERY (RCA), THE 2.75 X 8 MM NC TREK BALLOON DILATATION CATHETER (BDC) MET RESISTANCE WHILE ADVANCING IN THE ANATOMY FOR STENT POST-DILATATION. THE DEVICE WAS USED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7785484 ↗
• MalfunctionApr 2, 2018Detachment Of Device Component; Kinked

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA). THE 2.75 X 8 MM NC TREK BALLOON CATHETER WAS PREPARED PER THE INSTRUCTION FOR USE FOR PRE-DILATATION. DURING THE ATTEMPT TO INSERT THE NC TREK INTO THE ROTATING HEMOSTATIC VALVE (RHV) WITH NO RESISTANCE NOTED, THE PROXIMAL SHAFT KINKED AT THE HUB AND SEPARATED. ANOTHER NC TREK WAS USED FOR PRE-DILATATION SUCCESSFULLY. A 2.5 X 15 MM XIENCE ALPINE WAS USED SUCCESSFULLY TO 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 Consequences Or Impact To Patient

  MAUDE report 7390899 ↗
• MalfunctionFeb 26, 2018Detachment Of Device Component; Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED, HEAVILY TORTUOUS, PROXIMAL CIRCUMFLEX CORONARY ARTERY. A NON-ABBOTT STENT WAS IMPLANTED. WHEN ADVANCING A 2.75X08MM NC TEK BALLOON DILATATION CATHETER (BDC), FOR POST DILATATION; RESISTANCE WAS FELT WITH THE GUIDING CATHETER. WHEN REMOVING THE BDC FROM THE GUIDING CATHETER RESISTANCE WAS FELT WITH THE GUIDE CATHETER AND THE DISTAL SHAFT SEPARATED IN THE GUIDE CATHETER. THE DISTAL SHAFT WAS REMOVED FROM THE GUIDE CATHETER BY HAND AND ANOTHER NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7297373 ↗
• MalfunctionNov 6, 2017Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY PROCEDURE TO TREAT A TARGET LESION IN THE HEAVILY CALCIFIED DIAGONAL ARTERY. THE 2.5 X 20 MM TREK DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION AND WAS INFLATED APPROXIMATELY 4 TIMES. ON THE LAST INFLATION, THE BALLOON RUPTURED AT 18 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND A 2.0 X 8 MM NC TREK DILATATION CATHETER WAS THEN ADVANCED AND INFLATED APPROXIMATELY 4 TIMES. ON THE LAST INFLATION, THE BALLOON RUPTURED AT 18 ATM. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND A 2.75 X 8 MM NC TREK DILATATION CATHETER WAS ADVANCED. THIS DEVICE WAS ALSO INFLATED APPROXIMATELY 4 TIMES AND RUPTURED ON THE LAST INFLATION AT 18 ATM. THE DEVICE WAS REMOVED WITHOUT ISSUE. ADDITIONAL TREK DILATATION CATHETERS WERE USED AND 2 STENTS WERE IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7004127 ↗
• MalfunctionMay 30, 2017Difficult to Remove

  REPORTEDLY, AN ATTEMPT TO USE A 2.75X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS MADE; HOWEVER, THE YELLOW PROTECTIVE SHEATH COULD NOT BE REMOVED. THE METAL STYLET WAS ABLE TO BE REMOVED. THE BDC WAS NOT USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER UNKNOWN BALLOON. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6598141 ↗
• MalfunctionMay 10, 2017Break; Nonstandard Device; Stretched; Physical Property Issue

  REPORTEDLY, A 2.75X8MM NC TREK BALLOON DILATATION CATHETER WAS DESCRIBED AS BEING DEFECTIVE. NO ADDITIONAL INFORMATION WAS PROVIDED. THE RETURN DEVICE ANALYSIS REVEALED THAT THE OUTER MEMBER WAS STRETCHED AT THE PROXIMAL END OF THE PROXIMAL BALLOON SEAL AND THE INNER MEMBER WAS SEPARATED AT THE PROXIMAL BALLOON MARKER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6558376 ↗
• InjuryMar 27, 2017Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE NC TREK WAS PREPARED FOR USE. THE PROTECTIVE SHEATH WAS DIFFICULT TO REMOVE; HOWEVER, IT WAS ABLE TO BE REMOVED AND THE DEVICE WAS USED. THE PATIENT UNDERWENT A CORONARY PROCEDURE TO TREAT A TARGET LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE NC TREK DILATATION CATHETER BALLOON WAS INFLATED, AT THE LESION, WITHOUT ISSUE, BUT THE BALLOON COULD NOT BE DEFLATED. A NON-ABBOTT INFLATION DEVICE WAS USED AND THEN REPLACED WITH A 20 CC SYRINGE AND A 30 CC SYRINGE. THE BALLOON WOULD NOT DEFLATE. THE PHYSICIAN FINALLY BROKE THE DILATATION CATHETER SHAFT AT A LOCATION OUTSIDE THE PATIENT ANATOMY AND THE BALLOON DEFLATED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6437226 ↗
• MalfunctionMar 22, 2017Difficult to Remove

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, THE PROTECTIVE SHEATH WAS UNABLE TO BE REMOVED FROM THE 2.75X8MM NC TREK. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6425820 ↗
• MalfunctionMar 17, 2017Inflation Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT 70% TO 80% STENOSED LESIONS IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND RIGHT CORONARY ARTERY (RCA). A 2.75 X 8 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS SELECTED FOR THE LESION IN THE LAD AND NO ISSUES NOTED DURING UNPACKING, INSPECTION AND PREPARATION PRIOR TO USE. THE BDC WAS ADVANCED WITH NO RESISTANCE TO THE LESION AND ON THE FIRST INFLATION ATTEMPT THE BALLOON WOULD NOT INFLATE. THE BDC WAS REMOVED FROM THE ANATOMY AND REPLACED WITH A NON-ABBOTT 2.75 X 8 MM BDC TO COMPLETE THE DILATATION OF THE LESION IN THE LAD. A 3.75 X 12 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS SELECTED FOR THE LESION IN THE RCA AND NO ISSUES NOTED DURING UNPACKING, INSPECTION AND PREPARATION PRIOR TO USE. THE BDC WAS ADVANCED WITH NO RESISTANCE TO THE LESION AND ON THE FIRST INFLATION ATTEMPT THE BALLOON WOULD NOT INFLATE. THE BDC WAS REMOVED FROM THE ANATOMY AND REPLACED WITH ANOTHER 3.75 X 12 MM NC TREK RX BDC TO COMPLETE THE DILATATION OF THE LESION IN THE RCA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6415652 ↗
• MalfunctionMar 1, 2017Break; Kinked

  IT WAS REPORTED THAT THE 2.75 X 8 MM NC TREK DILATATION WAS NOTED TO BE KINKED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS NOTED THAT THE INNER MEMBER WAS SEPARATED AT THE PROXIMAL BALLOON MARKER, BUT THE OUTER MEMBER REMAINED INTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6368500 ↗
• MalfunctionSep 28, 2016Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT BEFORE USE A 2.75X8MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS BEING PREPPED AND THE STYLET COULD NOT BE REMOVED. THE PHYSICIAN ATTEMPTED TO REMOVE THE STYLET AND THE BALLOON CATHETER SEPARATED INTO TWO PIECES. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW SAME SIZE NC TREK WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5984112 ↗