FDA Adverse Event
Malfunction
Summary report: N
EXTRACTOR PRO RX
MDR report key: 20407369
·
Received October 9, 2024
Report
- Report Number
- 3005099803-2024-04991
- Event Type
- Malfunction
- Date Received
- October 9, 2024
- Date of Event
- September 17, 2024
- Report Date
- October 9, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729790266
- PMA / PMN Number
- K102082
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 AN EXTRACTOR PRO RETRIEVAL BALLOON WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RETRIEVAL 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 |
|---|---|---|---|---|---|---|---|
| 20466 | EXTRACTOR PRO RX | CATHETER, BILIARY, DIAGNOSTIC | FGE | BOSTON SCIENTIFIC CORPORATION | M00547000 | 0033833581 | 08714729790266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |