FDA Adverse Event
Malfunction
Summary report: N
CRE FIXED WIRE
MDR report key: 20071237
·
Received August 26, 2024
Report
- Report Number
- 3005099803-2024-03948
- Event Type
- Malfunction
- Date Received
- August 26, 2024
- Date of Event
- August 1, 2024
- Report Date
- August 26, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNQ
- UDI-DI
- 08714729202011
- PMA / PMN Number
- K971320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
- 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 ATTEMPTED TO BE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON COULD NOT BE DEFLATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE FIXED WIRE 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 |
|---|---|---|---|---|---|---|---|
| 969006 | CRE FIXED WIRE | DILATOR, ESOPHAGEAL | KNQ | BOSTON SCIENTIFIC CORPORATION | M00558380 | 0033186857 | 08714729202011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |