FDA Adverse Event
Malfunction
Summary report: N
CRE PRO
MDR report key: 19669030
·
Received July 3, 2024
Report
- Report Number
- 3005099803-2024-03054
- Event Type
- Malfunction
- Date Received
- July 3, 2024
- Date of Event
- June 7, 2024
- Report Date
- July 3, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729797593
- PMA / PMN Number
- K112994
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- 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 PRO WIREGUIDED DILATATION BALLOON WAS USED IN THE ESOPHAGUS DURING A GASTROINTESTINAL DILATION (GI DILATION) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE COMPLETELY. IT WAS REPORTED THAT THE DEVICE WAS CUT OUT OF THE ENDOSCOPE TO BE REMOVED AFTER DILATION. THE PROCEDURE WAS ALREADY SUCCESSFULLY COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 977600 | CRE PRO | CATHETER, BILIARY, DIAGNOSTIC | FGE | BOSTON SCIENTIFIC CORPORATION | M00558710 | 0032293938 | 08714729797593 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |