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

Model Number	M00561241
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
Note: this report pertains to the second of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2017-02298 and 3005099803-2017-02293 for the other associated device information.It was reported to boston scientific corporation that three captivator ii snares were used in the sigmoid colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2017.According to the complainant, during the procedure and inside the patient, the snare loop broke on three devices used consecutively.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.It was reported that the patient had ¿no injury¿ at the conclusion of the procedure.

• Brand Name: CAPTIVATOR¿ II
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6760673
• Report Number: 3005099803-2017-02299
• Device Sequence Number: 1565957
• Product Code: FDI
• UDI-Device Identifier: 08714729855927
• UDI-Public: (01)08714729855927(17)20200502(10)0020597774
• Combination Product (Y/N): N
• PMA/510(K) Number: K133987
• 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): 07/12/2017

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: 05/02/2020
• Device Model Number: M00561241
• Device Catalogue Number: 6124
• Device Lot Number: 0020597774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1