NC TREK 1012452-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08717648152030), received between Aug 11, 2016 and Jan 13, 2025 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (14 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Break; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Break; Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE 3.75X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) RUPTURED DURING THE FIRST INFLATION AT 14 ATMOSPHERES. A 3.75X15 MM NC TREK BDC WAS INFLATED THREE TIMES TO 12 ATMOSPHERES; THE BALLOON ONLY PARTIALLY DEFLATED. THE BDC WAS REMOVED PARTIALLY DEFLATED. A NON-ABBOTT DEVICE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21142694 ↗
• MalfunctionDec 19, 2024Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method

  SUBSEQUENTLY, AFTER THE INITIAL REPORT WAS FILED IT WAS REPORTED THAT RESISTANCE WAS FELT WITH THE ANATOMY DURING REMOVAL OF THE NC TREK BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20981608 ↗
• MalfunctionSep 3, 2024Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Material Rupture; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. REPORTEDLY A 3.75X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 12-14 ATMOSPHERES; HOWEVER, THE BALLOON WAS UNABLE TO BE DEFLATED. RESISTANCE WAS NOTED DURING THE REMOVAL AND THE BDC WAS UNABLE TO BE REMOVED THROUGH THE 6F GUIDING CATHETER (GC). THE BALLOON WAS NOTED TO HAVE RUPTURED WITHIN THE SHAFT OF THE GC. THE DEVICE WAS REMOVED, AND ANOTHER NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE DEVICE RETURN ANALYSIS REVEALED THAT THE INNER AND OUTER MEMBER OF THE SHAFT WERE SEPARATED, AND THE PROXIMAL PORTION WAS NOT RETURNED. THESE DAMAGES WERE UNABLE TO BE CONFIRMED BY THE ACCOUNT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125776 ↗
• MalfunctionJul 23, 2024Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 3.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ATTEMPTED TO BE ADVANCED TO THE TARGET LESION; HOWEVER, RESISTANCE WAS NOTED WITH THE ANATOMY AND THE PROXIMAL SHAFT OF THE BDC SEPARATED IN 2 PIECES WHEN A SMALL AMOUNT OF FORCE WAS APPLIED. THE SEPARATION OCCURRED OUTSIDE THE PATIENT ANATOMY; THEREFORE, THE BDC WAS SIMPLY REMOVED. ANOTHER NC TREK BDC WAS USED TO CONTINUE 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 19811402 ↗
• MalfunctionJun 22, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHEN REMOVING THE PROTECTIVE SHEATH FROM THE NC TREK BALLOON DILATATION CATHETER (BDC) DURING PREPARATION, THERE WAS RESISTANCE. ADDITIONALLY, THE SUPPORT SHAFT [STYLET/MANDREL] WAS STUCK INSIDE THE BALLOON SO THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW, SAME SIZE NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041789 ↗
• MalfunctionJan 12, 2021Material Separation; Deformation Due to Compressive Stress; Material Separation; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 3.75X15MM NC TREK BALLOON WAS ADVANCED OVER THE GUIDE WIRE WHEN IT BECAME KINKED AND SUBSEQUENTLY THE MID-SHAFT BROKE (HAVING NOT ENTERED THE ANATOMY YET). THE DEVICE WAS SIMPLY REMOVED ALTOGETHER. ANOTHER NC TREK 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 Consequences Or Impact To Patient

  MAUDE report 11155901 ↗
• MalfunctionNov 10, 2020Material 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 90% STENOSED LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPPED (AIR ASPIRATED) WHILE INSIDE THE PATIENT ANATOMY. THE BDC WAS THEN ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION. THE BALLOON WAS INFLATED ONCE; HOWEVER, IT RUPTURED BELOW RATE OF BURST PRESSURE AT 12 ATMOSPHERES. THE BDC WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SAME SIZE NC TREK BDC. 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 10820664 ↗
• MalfunctionJul 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS CORONARY INTERVENTION TO TREAT THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE NC TREK DILATED THE IMPLANTED STENT. THE NC TREK WAS DEFLATED AND WHEN IT WAS BEING REMOVED, THE SHAFT SEPARATED, THE SEPARATED SEGMENT CAME OUT WITH THE GUIDE WIRE. 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 10277328 ↗
• MalfunctionApr 13, 2020Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THAT WAS 90% STENOSED. A 3.75X15MM NC TREK BALLOON WAS ADVANCED TO THE LESION WITH SOME RESISTANCE DUE TO ANATOMY AND RUPTURED ON THE FIRST INFLATION AT 8 ATMOSPHERES. A SAME SIZE NON-ABBOTT BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE DILATATION AND THEN IMPLANT A XIENCE STENT TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9954979 ↗
• MalfunctionFeb 10, 2020Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT DURING PREPARATION, BEFORE ADVANCING THE 3.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) INTO THE COPILOT, THE SHAFT SEPARATED NEAR THE BALLOON. THE DEVICE WAS NOT USED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9687248 ↗
• MalfunctionMay 30, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PREPARATION AND BEFORE USE, THE PROTECTIVE SHEATH WAS FIRMLY STUCK TO THE BALLOON AND COULD NOT BE REMOVED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8656838 ↗
• MalfunctionNov 20, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BEFORE USE, THE PROTECTIVE SHEATH COULD NOT BE REMOVED FROM THE 3.75X15 MM NC TREK BALLOON DILATATION CATHETER (BDC). THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW, SAME SIZE NC TREK WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8092647 ↗
• MalfunctionJun 12, 2018Difficult To Position; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS A PERCUTANEOUS CORONARY INTERVENTION PERFORMED WITH A 3.75 X 15 MM NC TREK DILATATION CATHETER. THE NC TREK WAS UNABLE TO BE ADVANCED OVER A BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE. THE GUIDE WIRE WOULD NOT EXIT THE GUIDE WIRE EXIT NOTCH. THE NC TREK WAS NOT INTRODUCED IN THE PATIENT. A NEW NC TREK WAS SUCCESSFULLY USED WITH THE SAME BMW GUIDE WIRE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS FOUND A STRETCHED SEGMENT ON THE SHAFT OF THE NC TREK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7592495 ↗
• MalfunctionJan 16, 2018Deflation Problem; Kinked

  IT WAS REPORTED THAT DURING A CORONARY ARTERY PROCEDURE, THE 3.75 X 15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED AT HIGH PRESSURE, BUT FAILED TO DEFLATE. ATTEMPTS WERE MADE TO DEFLATE THE BALLOON, BUT IT WOULD NOT DEFLATE, SO THE DEVICE WAS SLOWLY REMOVED AND THE PROXIMAL SHAFT KINKED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7197846 ↗
• MalfunctionJun 20, 2017Inflation Problem

  IT WAS REPORTED THAT AN NC TREK DILATATION CATHETER WAS ADVANCED TO THE RIGHT CORONARY ARTERY (RCA), PREVIOUSLY STENTED SITE, WITHOUT ISSUE. DILATATION WAS ATTEMPTED, HOWEVER THE BALLOON FAILED TO INFLATE. THERE WAS NO INFLATION AT ALL. THE DEVICE WAS REMOVED FROM THE PATIENTS ANATOMY WITHOUT ISSUE AND ANOTHER DEVICE WAS USED IN REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6655633 ↗
• MalfunctionMay 9, 2017Material Rupture; Physical Resistance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED, ECCENTRIC, DE NOVO, 90% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY. AFTER PRE-DILATATION WITH A NON-ABBOTT 2.5 X 10 MM BALLOON CATHETER THE LESION WAS OBSERVED BY OPTICAL FREQUENCY DOMAIN IMAGING (OFDI). ADDITIONAL DILATATION WAS PERFORMED WITH THE NC TREK 3.75 X 15 MM; HOWEVER, THE BALLOON RUPTURED DURING THE THIRD INFLATION AT 18 ATMOSPHERES. THERE WAS RESISTANCE WITH THE ANATOMY DURING ADVANCEMENT TO THE TARGET LESION BUT THERE WAS NO RESISTANCE NOTED DURING REMOVAL FROM THE ANATOMY. A NON-ABBOTT 4.0 X 32 MM STENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED AFTER POST-DILATATION WITH A NON-ABBOTT 4.0 X 15 MM BALLOON CATHETER. THE DEVICE WAS PREPARED OUTSIDE OF THE PATIENT ANATOMY, THE BALLOON WAS SOAKED IN SALINE PRIOR TO USE OF THE DEVICE AND THERE WAS NO RESISTANCE NOTED DURING THE REMOVAL OF THE PROTECTIVE SHEATH. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6554177 ↗
• MalfunctionApr 28, 2017Difficult to Remove

  IT WAS REPORTED THAT THE PROTECTIVE SHEATH OF THE NC TREK RX 3.75 X 15 MM BALLOON DILATATION CATHETER WAS DIFFICULT TO REMOVE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW NC TREK 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 6530500 ↗
• MalfunctionApr 27, 2017Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO THREAT A DE NOVO CONCENTRIC LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION THAT WAS 90% STENOSED. RESISTANCE WAS NOT FELT DURING THE ADVANCEMENT OF THE 3.75MM X 15 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) FOR PRE-DILATATION AND IT CROSSED THE LESION SUCCESSFULLY; HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 7 ATMOSPHERES. IT WAS STATED THAT AIR ASPIRATION (DEVICE PREP) WAS PERFORMED INSIDE THE ANATOMY. A NEW 3.5 X 15 MM NC TREK BDC WAS USED FOR PRE-DILATATION. THE PROCEDURE WAS COMPLETED AFTER A NON-ABBOTT SENT WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6526677 ↗
• MalfunctionMar 31, 2017Break; Kinked; Nonstandard Device; Stretched

  IT WAS REPORTED THAT AFTER UNPACKING, IT WAS OBSERVED THAT THE SHAFT WAS ALREADY KINKED. THE DEVICE WAS NOT USED IN THE PATIENT'S ANATOMY. THERE WAS NO PATIENT INVOLVEMENT. ANOTHER NC TREK WAS USED TO FINISH THE PROCEDURE. THE PATIENT IS DOING WELL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED DUE TO THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED. ANALYSIS OF THE RETURNED DEVICE BY THE RG LAB IDENTIFIED THAT THE OUTER MEMBER WAS STRETCHED AT THE PROXIMAL SEAL AND THE INNER MEMBER WAS SEPARATED AT THE PROXIMAL BALLOON MARKER.

  Patient problems: No Patient Involvement

  MAUDE report 6449757 ↗
• MalfunctionMar 17, 2017Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT THE YELLOW PROTECTIVE SHEATH WAS UNABLE TO BE REMOVED FROM THE 3.75X15 MM NC TREK AND THE BALLOON SEPARATED IN THE SHEATH. THE NC TREK WAS NOT USED IN THE PATIENT. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6413689 ↗
• MalfunctionMar 10, 2017Inflation Problem

  IT WAS REPORTED THAT THE 3.75 X 15 MM NC TREK DILATATION CATHETER WAS PREPARED FOR USE PER INSTRUCTIONS FOR USE AND NO ISSUES WERE NOTED. THE DEVICE WAS ADVANCED TO THE TARGET LESION WITHOUT DIFFICULTY. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON, USING AN INDEFLATOR AT 14 ATMOSPHERES (ATM); HOWEVER, THE BALLOON WOULD NOT INFLATE. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND WAS NOTED TO BE UNINFLATED. A NON-ABBOTT DILATATION CATHETER WAS USED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6396622 ↗
• MalfunctionMar 1, 2017Detachment Of Device Component; Kinked

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNKNOWN LESION. THE NC TREK RX 3.75 X 15 MM BALLOON DILATATION CATHETER WAS KINKED AT THE BALLOON SHAFT. IT IS UNKNOWN IF THE ISSUE OCCURRED DURING PREPARATION OR AFTER USE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION CAN BE PROVIDED. DEVICE ANALYSIS REVEALED AN INNER MEMBER SEPARATION AT THE PROXIMAL BALLOON MARKER; THE INNER MEMBER MATERIAL AT THE SEPARATION WAS STRETCHED AND JAGGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370080 ↗
• MalfunctionJan 13, 2017Detachment Of Device Component; Difficult To Position

  IT WAS REPORTED THAT THE 3.75X15MM NC TREK BALLOON DILATATION CATHETER (BDC) COULD NOT BE ADVANCED OVER A NON-ABBOTT GUIDE WIRE. WHEN TRYING TO LOAD THE BDC ON THE GUIDE WIRE AND INTO THE GUIDE CATHETER THE HYPOTUBE SEPARATED. THUS, THE NC TREK BDC COULD NOT BE USED FOR POST-DILATATION. A NON-ABBOTT BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6252013 ↗
• MalfunctionDec 15, 2016Detachment Of Device Component; Difficult to Remove

  IT WAS REPORTED THAT PRIOR TO USE, THE 3.75X15 MM NC TREK RX BALLOON WAS STUCK IN THE PROTECTIVE SHEATH; THE PROTECTIVE SHEATH COULD NOT BE REMOVED AND THE SHAFT SEPARATED. THE NC TREK WAS NOT USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. AN UNSPECIFIED BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6178308 ↗
• MalfunctionNov 14, 2016Inflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, RESISTANCE WAS MET DURING REMOVAL OF THE PROTECTIVE BALLOON SHEATH AND THE DEVICE WAS NOT SUBMERGED TO ACTIVATE THE COATING. THE DEVICE WAS TAKEN TO THE LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND WAS POSITIONED, BUT FAILED TO INFLATE. THE DEVICE WAS REMOVED AND A DIFFERENT DEVICE WAS USED IN THE PROCEDURE 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 6099889 ↗