CRE PULMONARY
Report
- Report Number
- 3005099803-2025-02456
- Event Type
- Malfunction
- Date Received
- May 30, 2025
- Date of Event
- April 28, 2025
- Report Date
- June 30, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KTI
- UDI-DI
- 08714729456216
- PMA / PMN Number
- K023337
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK E1: INITIAL REPORTERS FACILITY NAME IS (B)(6); REPORTED HERE AS THE FACILITY NAME EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. 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 TRACHEA.
BLOCK H2 (ADDITIONAL INFORMATION): BLOCK E1 (INITIAL REPORTER ADDRESS AND ZIP/POST CODE) HAVE BEEN UPDATED. BLOCK E1: INITIAL REPORTERS FACILITY NAME IS THE FIRST AFFILIATED HOSPITAL OF SHANDONG FIRST MEDICAL UNIVERSITY; REPORTED HERE AS THE FACILITY NAME EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. 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 TRACHEA. BLOCK H11: INVESTIGATION RESULTS THE RETURNED CRE PULMONARY DILATATION BALLOON WAS ANALYZED AND A VISUAL INSPECTION FOUND NO PHYSICAL DAMAGE. A FUNCTIONAL EVALUATION FOUND THE BALLOON INFLATED WITHOUT PROBLEMS BUT WAS NOT ABLE TO HOLD PRESSURE DUE TO A PINHOLE WHICH PRODUCES A LEAK. MICROSCOPIC EVALUATION FOUND THE BALLOON HAD A PINHOLE LOCATED APPROXIMATELY 20MM FROM THE TIP OF THE DEVICE. 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 WAS INFLATED WITHOUT PROBLEMS HOWEVER IT WAS NOT ABLE TO HOLD PRESSURE DUE TO A PINHOLE LOCATED APPROXIMATELY 20MM FROM THE TIP OF THE DEVICE. IT IS POSSIBLE THAT THE PINHOLE 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 PINHOLE. 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 TRACHEA DURING A TRACHEAL STENOSIS PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THERE WAS A LEAKAGE OF FLUID FROM THE FRONT END OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS. 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 TRACHEA DURING A TRACHEAL STENOSIS PROCEDURE TO TREAT STENOSIS PERFORMED ON (B)(6), 2025. DURING THE PROCEDURE, THERE WAS A LEAKAGE OF FLUID FROM THE FRONT END OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY DILATATION BALLOON. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-FAITH EFFORTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35367 | CRE PULMONARY | BRONCHOSCOPE ACCESSORY | KTI | BOSTON SCIENTIFIC CORPORATION | M00550330 | 0033159260 | 08714729456216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female |