FDA Adverse Event
Malfunction
Summary report: N
CRE FIXED WIRE
MDR report key: 18279343
·
Received December 6, 2023
Report
- Report Number
- 3005099803-2023-06536
- Event Type
- Malfunction
- Date Received
- December 6, 2023
- Date of Event
- November 15, 2023
- Report Date
- December 6, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNQ
- UDI-DI
- 08714729195993
- PMA / PMN Number
- K971320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A140101 CAPTURES THE REPORTABLE EVENT OF BALLOON FAILURE TO DEFLATE.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE FIXED WIRE DILATATION BALLOON WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) , 2023. DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE AND HAD TO BE PUNCTURED TO REMOVE IT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THE EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 198314 | CRE FIXED WIRE | DILATOR, ESOPHAGEAL | KNQ | BOSTON SCIENTIFIC CORPORATION | M00558370 | 0032356355 | 08714729195993 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |