EXTRACTOR PRO XL
Report
- Report Number
- 3005099803-2023-03627
- Event Type
- Malfunction
- Date Received
- July 7, 2023
- Date of Event
- June 14, 2023
- Report Date
- October 2, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FGE
- UDI-DI
- 08714729790402
- PMA / PMN Number
- K102082
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF TIP BENT.
BLOCK H6: IMDRF DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF TIP BENT. BLOCK H10: INVESTIGATION RESULT: THE RETURNED EXTRACTOR PRO XL RETRIEVAL BALLOON WAS ANALYZED, AND A VISUAL EXAMINATION OF DEVICE FOUND THAT THE BALLOON AND THE CATHETER OF DEVICE HAD NO DAMAGES. MICROSCOPIC INSPECTION FOUND THE TIP OF THE BALLOON WAS BENT. NO OTHER PROBLEMS WITH THE DEVICE WERE NOTED. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THE REPORTED EVENT OF THE BALLOON TIP BENT WAS CONFIRMED. IT IS POSSIBLE THAT FACTORS ENCOUNTERED DURING THE PROCEDURE MAY HAVE CAUSED THE BALLOON TIP TO BEND, SUCH AS EXCESS FORCE DURING DEVICE UNPACKING OR DURING INSERTION THROUGH THE SCOPE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE DISTAL COMMON BILE DUCT FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO XL RETRIEVAL BALLOON WAS USED IN THE DISTAL COMMON BILE DUCT FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR PRO RETRIEVAL BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149178 | EXTRACTOR PRO XL | CATHETER, BILIARY, DIAGNOSTIC | FGE | BOSTON SCIENTIFIC CORPORATION | M00547110 | 0029484114 | 08714729790402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |