ROTOSNARE
Report
- Report Number
- 3005099803-2011-01554
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Report Date
- April 4, 2011
- Manufacturer
- BOSTON SCIENTIFIC - COSTA RICA
- Product Code
- FDI
- PMA / PMN Number
- K992477
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4) RELATES TO (B)(4) FOR THE REPORTABLE EVENT: HANDLE CANNULA DETACHED. THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE HANDLE CANNULA BENT; NO KINKS WERE NOTED ALONG THE WORKING LENGTH. THE HANDLE WAS DISASSEMBLED, AND RESISTANCE WAS MET AT THE DONGLE SECTION WHEN THE DEVICE WAS ACTUATED. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE HANDLE BROKE AND THE DEVICE WAS DIFFICULT TO EXTEND; THE COMPLAINT WAS CONFIRMED. THE RESISTANCE IN THE DONGLE SECTION OF THE DEVICE LIKELY CAUSED DIFFICULTY EXTENDING, WHICH SUBSEQUENTLY CAUSED THE HANDLE CANNULA TO BEND WHEN FORCE WAS APPLIED TO ACTUATE THE DEVICE. THE MOST PROBABLE ROOT CAUSE OF THIS FAILURE IS A MANUFACTURING ISSUE, AND A CORRECTION HAS BEEN IMPLEMENTED TO ADDRESS THIS ISSUE. IT WAS CONFIRMED THAT THIS LOT WAS MANUFACTURED PRIOR TO THE CORRECTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE INITIAL MDR REPORTED THAT THE HANDLE BROKE WHEN THE PHYSICIAN APPLIED ADDITIONAL FORCE, BUT THE NATURE OF THE DAMAGE TO THE HANDLE COULD NOT BE CONFIRMED. THE INVESTIGATION FOUND THAT THE HANDLE CANNULA WAS BENT AND THE LOOP FAILED TO EXTEND; HOWEVER, THESE ARE NOT REPORTABLE EVENTS.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE (PROCEDURE DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE SNARE LOOP WOULD NOT EXTEND WHEN THE PHYSICIAN ACTUATED THE DEVICE HANDLE, AND THE HANDLE BROKE WHEN THE PHYSICIAN APPLIED ADDITIONAL FORCE. IT IS UNKNOWN WHETHER THE HANDLE CANNULA DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ROTATABLE OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE (PROCEDURE DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE SNARE LOOP WOULD NOT EXTEND WHEN THE PHYSICIAN ACTUATED THE DEVICE HANDLE, AND THE HANDLE BROKE WHEN THE PHYSICIAN APPLIED ADDITIONAL FORCE. IT IS UNKNOWN WHETHER THE HANDLE CANNULA DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ROTATABLE OVAL SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROTOSNARE | SNARE, FLEXIBLE | FDI | BOSTON SCIENTIFIC - COSTA RICA | M00561821 | 13208919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |