MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CAPTIVATOR¿; SNARE, FLEXIBLE

Model Number	M00561311
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.
Event or Problem Description
It was reported to boston scientific corporation that a captivator large oval snare was used in the colon during a colonoscopy with polypectomy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the snare failed to deliver current and was unable to cut the target polyp.It was noted that the catheter was detached and the wire inside the sheath was broken.The procedure was completed with another captivator 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 fine.
Additional Manufacturer Narrative
Investigation results: visual evaluation of the returned device revealed that the catheter was damaged; it was torn and has evidence of melting at 10.2 cm to 13.1 cm from the flare section.The cautery pin was disassembled and was found to have evidence of burn at the middle section.Electrical resistance testing was performed and resistance measured at 10.9 ohms, within manufacturing specifications.The reported complaint was confirmed.Due to anatomical/procedural factors encountered during the procedure; performance of the device was limited.Therefore, the most probable root cause classification is operational context.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a captivator large oval snare was used in the colon during a colonoscopy with polypectomy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the snare failed to deliver current and was unable to cut the target polyp.It was noted that the catheter was detached and the wire inside the sheath was broken.The procedure was completed with another captivator 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 fine.

• Brand Name: CAPTIVATOR¿
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7037057
• Report Number: 3005099803-2017-03401
• Device Sequence Number: 10997780
• Product Code: FDI
• UDI-Device Identifier: 08714729019251
• UDI-Public: 08714729019251
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K941750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2020
• Device Model Number: M00561311
• Device Catalogue Number: 6131
• Device Lot Number: 0020883454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1