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

Model Number	M00561831
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and 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 during a polypectomy procedure performed on (b)(6) 2021.During the procedure and inside the patient, when colon polyp was tried to remove using this device, it could not be removed since it was noted that the sharpness was not good, so it was judged as defective.Reportedly, there were no other issues noted with the device.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: (initial reporter city) (b)(6).Block h6: problem code a050702 captures the reportable event of snare loop difficulty resecting the target polyp.Block h10: (product investigation) the returned rotatable snare was analyzed, and a visual evaluation noted no problems with the device.During functional evaluation, the device was connected to the 10 inch loop fixture and the loop extended and contracted without issues.A continuity test was done and the device passed since the electrical resistance was within specification, indicating a proper connection.The reported event of "loop failure to cut" could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.Additionally, the device passed the continuity test upon return.The product record review confirmed that this is not a new failure type and the risk is anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found no issues with the device during visual and functional test.No issues were noted with the electrical device testing during continuity test.Based on the device analysis and the available information, the most probable cause classification is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a rotatable medium oval med stiff snare was used during a polypectomy procedure performed on (b)(6) 2021.During the procedure and inside the patient, when colon polyp was tried to remove using this device, it could not be removed since it was noted that the sharpness was not good, so it was judged as defective.Reportedly, there were no other issues noted with the device.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.

• 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: 11778248
• Report Number: 3005099803-2021-02008
• Device Sequence Number: 3647409
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 01/18/2024
• Device Model Number: M00561831
• Device Catalogue Number: 6183
• Device Lot Number: 0026648960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1