CRE PULMONARY
Report
- Report Number
- 3005099803-2025-05012
- Event Type
- Malfunction
- Date Received
- September 30, 2025
- Date of Event
- September 5, 2025
- Report Date
- December 4, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KTI
- UDI-DI
- 08714729456193
- PMA / PMN Number
- K023337
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IC
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK G4: THE REMAINING PREMARKET/510(K) NUMBER IS K170759; REPORTED HERE AS PREMARKET/510(K) NUMBER EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0504 CAPTURES THE REPORTABLE EVENT OF A BALLOON LEAK. BLOCK H11: INVESTIGATION RESULTS THE RETURNED CRE PULMONARY DILATATION BALLOON WAS ANALYZED, AND A VISUAL EXAMINATION FOUND THAT THE BALLOON HAD NO DAMAGES. FUNCTIONAL AND MICROSCOPIC INSPECTION WAS PERFORMED, THE BALLOON WAS INFLATED WITHOUT ANY PROBLEM; HOWEVER, IT WAS NOT ABLE TO HOLD PRESSURE DUE TO A PINHOLE IN THE BALLOON, WHICH PRODUCES A LEAK, LOCATED APPROXIMATELY 84 MM FROM THE TIP. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF BALLOON LEAK WAS CONFIRMED. THE ANALYSIS ON THE RETURNED DEVICE FOUND THAT THE BALLOON HAD A PINHOLE LOCATED APPROXIMATELY AT 84 MM FROM THE TIP OF THE DEVICE. IT IS POSSIBLE THAT THE PINHOLE FOUND IN THE BALLOON OCCURRED DUE TO PROCEDURAL FACTORS SUCH AS EXCESS OF PRESSURE OR INTERACTION WITH OTHER DEVICES. ALSO, IT IS POSSIBLE THAT INTERACTION WITH A SHARP SURFACE DURING/PREVIOUS THE PROCEDURE, COULD HAVE CAUSED THE PINHOLE FOUND ON THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU) / PRODUCT LABEL.
BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G4: THE REMAINING PREMARKET/510(K) NUMBER IS K170759; REPORTED HERE AS PREMARKET/510(K) NUMBER EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A0504 CAPTURES THE REPORTABLE EVENT OF A BALLOON LEAK.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE THROAT DURING A TRACHEOSCOPY WITH BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A LEAK WAS NOTICED IN THE CRE BALLOON DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE THROAT DURING A TRACHEOSCOPY WITH BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A LEAK WAS NOTICED IN THE CRE BALLOON DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2215291 | CRE PULMONARY | BRONCHOSCOPE ACCESSORY | KTI | BOSTON SCIENTIFIC CORPORATION | M00550310 | 0036363534 | 08714729456193 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female |