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

Model Number	M00562471
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: visual evaluation of the returned device revealed that the snare loop was broken with evidence of being burned.Further examination noted that the handle cannula was found to be in good condition.A functional analysis was not performed due to the condition of the returned device.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 other complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex extra small oval snare was used during a colonoscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, after the polyp was cut it was necessary to use cautery to stop the bleeding and it was noted that the wire inside the handle broke.The procedure was completed with another captiflex 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 stable.This event has been deemed a reportable event based on the investigation results; loop broken.

• Brand Name: CAPTIFLEX¿
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7556597
• Report Number: 3005099803-2018-01663
• Device Sequence Number: 19453376
• Product Code: FDI
• UDI-Device Identifier: 08714729019459
• UDI-Public: 08714729019459
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K941750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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: Physician
• Device Expiration Date: 05/10/2020
• Device Model Number: M00562471
• Device Catalogue Number: 6247
• Device Lot Number: 20632795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR