MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE

Model Number	M00562652
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
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 sensation large oval med stiff snare was used for polyp removal in the colon during a colonoscopy with polypectomy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the physician stated that when the snare was fully looped around the target polyp and cut energy was applied, nothing would happen despite the erbe generator indicating that it was delivering energy.They also attempted to change the cautery settings and reposition the snare.The snare was securely attached to the active cord and no visible issue was noted with the cautery pin.No signs of blanching and no other issues noted with the device.The procedure was completed with a different snare size.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation that a sensation large oval med stiff snare was used for polyp removal in the colon during a colonoscopy with polypectomy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the physician stated that when the snare was fully looped around the target polyp and cut energy was applied, nothing would happen despite the erbe generator indicating that it was delivering energy.They also attempted to change the cautery settings and reposition the snare.The snare was securely attached to the active cord and no visible issue was noted with the cautery pin.No signs of blanching and no other issues noted with the device.The procedure was completed with a different snare size.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.
Additional Manufacturer Narrative
Block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results: a sensation large oval med stiff snare was received for analysis.Visual inspection of the returned device revealed that the loop was within specifications and that the tip of the working length was melted.Electrical test was performed and the device passed, indicating a proper connection.Functional inspection was performed and when the device was connected to the 10 inch loop fixture, the loop extended and contracted without problems.No other problems were noted.The reported event of "loop failure to cut" was not confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported event of "device failure to deliver energy" was unable to be confirmed since the electrical test passed.Device analysis found that the tip of the working length was melted as result of the interaction of the loop with the working length when the energy was applied in the device.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is "no problem detected." this code was selected as the most probable cause since the reported events of loop failure to cut and device failure to deliver energy were not able to be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: SENSATION SHORT THROW
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12418165
• Report Number: 3005099803-2021-04559
• Device Sequence Number: 20014711
• Product Code: FDI
• UDI-Device Identifier: 08714729268802
• UDI-Public: 08714729268802
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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: 06/12/2022
• Device Model Number: M00562652
• Device Catalogue Number: 6265-20
• Device Lot Number: 0023950027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown