MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTATABLE SNARE; SNARE, FLEXIBLE

Model Number	M00561831
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter's address: (b)(6).(b)(4).The device has been received for analysis; however 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable medium oval med stiff snare was used in the rectum during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the snare was inserted from the scope channel of the endoscope.When the snare loop was extended to remove the rectal polyp, the tip part of the wire got unraveled so the usage was stopped.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: the initial reporter's address is (b)(6).Block h6: problem code 1069 captures the reportable event of snare loop broken.Block h10: investigation results a rotatable medium oval med stiff snare was received for analysis.Visual inspection of the returned device revealed that the tip part of the snare loop was unraveled.No other issues were noted.It is most likely that this failure mode was caused during the procedure and may be related with some factors as lesion characteristics, handling of the device, the technique used by the physician and normal procedural difficulties.Taking into consideration the evaluation conducted at the complaint investigation site and the details of the complaint, the most probable conclusion code assigned to this investigation is adverse event related to the procedure, this indicates that the failure mode occurred during the procedure and the device had no influence on the event.A risk review of the rotatable was completed using (b)(6), rotatable snares process fmea, bsc, bk.3 and confirmed that the event of loop break was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable medium oval med stiff snare was used in the rectum during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the snare was inserted from the scope channel of the endoscope.When the snare loop was extended to remove the rectal polyp, the tip part of the wire got unraveled so the usage was stopped.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

• Brand Name: ROTATABLE SNARE
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9641667
• Report Number: 3005099803-2020-00130
• Device Sequence Number: 14185071
• Product Code: FDI
• UDI-Device Identifier: 08714729283997
• UDI-Public: 08714729283997
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160637
• 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,Followup
• Report Date (Section B): 02/28/2020

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: 08/19/2022
• Device Model Number: M00561831
• Device Catalogue Number: 6183
• Device Lot Number: 0024288256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1