EXTRACTOR? PRO RX
Report
- Report Number
- 3005099803-2014-02555
- Event Type
- Injury
- Date Received
- July 18, 2014
- Report Date
- June 27, 2014
- Manufacturer
- BOSTON SCIENTIFIC - CORK
- Product Code
- FGE
- PMA / PMN Number
- K102082
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.
A VISUAL EXAMINATION OF THE COMPLAINT DEVICE REVEALED THAT THE BALLOON WAS DETACHED FROM THE CATHETER. THE REST OF THE CATHETER WAS EXAMINED AND NO ISSUES WERE NOTED. THE DETACHED BALLOON WAS RETURNED AND THE DISTAL TIP WAS INTACT. THE BALLOON BONDS WERE FOUND TO BE CONTINUOUS AND INTACT. IT IS LIKELY THAT THE BALLOON COULD HAVE BEEN BURST AND THEN DETACHED FROM THE CATHETER UPON CATHETER WITHDRAWAL. THE MOST PROBABLE ROOT CAUSE OF OPERATIONAL CONTEXT WILL BE ASSIGNED TO THIS COMPLAINT AS IT IS MOST LIKELY THAT THE COMPLAINT WAS DUE TO SOME PROCEDURAL/ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED PERFORMANCE OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, THE BALLOON POPPED OFF AT FULL INFLATION. IT IS UNCLEAR FROM THE INFORMATION AVAILABLE WHETHER THE BALLOON MATERIAL DETACHED OR IF THE DISTAL TIP DETACHED. REPORTEDLY, THEY WERE ABLE TO RETRIEVE THE DETACHED FRAGMENT SUCCESSFULLY WITH A RAT TOOTH RETRIEVAL DEVICE. THE PROCEDURE WAS FINISHED WITH ANOTHER EXTRACTOR BALLOON. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF FURTHER INFORMATION IS OBTAINED, A SUPPLEMENTAL MDR WILL BE FILED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, THE BALLOON POPPED OFF AT FULL INFLATION. IT IS UNCLEAR FROM THE INFORMATION AVAILABLE WHETHER THE BALLOON MATERIAL DETACHED OR IF THE DISTAL TIP DETACHED. REPORTEDLY, THEY WERE ABLE TO RETRIEVE THE DETACHED FRAGMENT SUCCESSFULLY WITH A RAT TOOTH RETRIEVAL DEVICE. THE PROCEDURE WAS FINISHED WITH ANOTHER EXTRACTOR BALLOON. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF FURTHER INFORMATION IS OBTAINED, A SUPPLEMENTAL MDR WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421448 | EXTRACTOR? PRO RX | CATHETER, BILIARY, DIAGNOSTIC | FGE | BOSTON SCIENTIFIC - CORK | M00547020 | 0016494762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |