CRE PULMONARY
Report
- Report Number
- 3005099803-2025-01206
- Event Type
- Malfunction
- Date Received
- March 31, 2025
- Date of Event
- March 3, 2025
- Report Date
- June 4, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KTI
- UDI-DI
- 08714729456223
- PMA / PMN Number
- K023337
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 IN THE RIGHT MAIN TRACHEA.
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 IN THE RIGHT MAIN TRACHEA. BLOCK H11: INVESTIGATION RESULTS, THE RETURNED CRE PULMONARY DILATATION BALLOON WAS ANALYZED, AND A VISUAL EVALUATION FOUND THE BALLOON WAS LONGITUDINALLY TORN. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC (BSC) CONCLUDES THE REPORTED EVENT OF BALLOON LEAK WAS CONFIRMED. THE RETURNED DEVICE REVEALED IT WAS LONGITUDINALLY TORN WHICH PRODUCED A LEAK. IT IS POSSIBLE THAT THE LONGITUDINAL TEAR FOUND ON THE BALLOON OCCURRED DUE TO PROCEDURAL FACTORS SUCH AS EXCESS PRESSURE OR INTERACTION WITH OTHER DEVICES, OR ANATOMICAL FACTORS. ALSO, IT IS POSSIBLE THAT INTERACTION WITH A SHARP SURFACE DURING OR PREVIOUS TO THE PROCEDURE COULD HAVE CAUSED THE BALLOON TEAR. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE RIGHT MAIN TRACHEA DURING A TRANSBRONCHOSCOPIC BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, AFTER UNPACKING, THE BALLOON DILATATION CATHETER ENTERED THE TRACHEAL STENOSIS POSITION THROUGH THE WORKING CHANNEL OF THE FIBEROPTIC BRONCHOSCOPE, AND IT WAS FOUND THAT THE DEVICE LEAKED WATER AFTER DILATATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE PULMONARY DILATATION BALLOON WAS ATTEMPTED TO BE USED IN THE RIGHT MAIN TRACHEA DURING A TRANSBRONCHOSCOPIC BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING PROCEDURE, AFTER UNPACKING, THE BALLOON DILATATION CATHETER ENTERED THE TRACHEAL STENOSIS POSITION THROUGH THE WORKING CHANNEL OF THE FIBEROPTIC BRONCHOSCOPE, AND IT WAS FOUND THAT THE DEVICE LEAKED WATER AFTER DILATATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1055053 | CRE PULMONARY | BRONCHOSCOPE ACCESSORY | KTI | BOSTON SCIENTIFIC CORPORATION | M00550340 | 0034694882 | 08714729456223 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male |