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

Model Number	M00562531
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 profile was used during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the snare failed to cut and remove the polyp.The procedure was completed with another profile.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.
Additional Manufacturer Narrative
Block h6: problem code 2587 captures the reportable event of failure to cut.Block h10: the returned profile was analyzed, and a visual evaluation noted that the device and cautery were found in good conditions.A functional evaluation noted that the loop extends and retracts properly.An electrical inspection was also performed and the device passed since the device's electrical resistance is within specification.No other issues with the device were noted.The reported event of loop failure to cut was not confirmed since the device cannot be evaluated with respect to anatomical/procedural factors encountered during the procedure.Additionally, the device passed the electrical resistance 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, electrical and functional test.Based on the information available, the investigation concluded that the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a profile was used during a polypectomy procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the snare failed to cut and remove the polyp.The procedure was completed with another profile.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.

• Brand Name: PROFILE
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11116862
• Report Number: 3005099803-2020-06499
• Device Sequence Number: 17156494
• Product Code: FDI
• UDI-Device Identifier: 08714729156628
• UDI-Public: 08714729156628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 08/23/2023
• Device Model Number: M00562531
• Device Catalogue Number: 6253
• Device Lot Number: 0025902237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1