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

Model Number M00561821

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

(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 Description

It was reported to boston scientific corporation that a rotatable small oval med stiff was to be used in the colon to remove a colon polyp during an endoscopic mucosal resection (emr) procedure on (b)(6) 2019.According to the complainant, during procedure and inside the patient, the snare was inserted into the endoscope and the first polyp was strangulated.After removal, the wire was retracted inside the sheath once.When the wire was pushed out again to remove the second polyp, it was found that the snare loop got broken, so the procedure was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 fine.

Event Description

It was reported to boston scientific corporation that a rotatable small oval med stiff was to be used in the colon to remove a colon polyp during an endoscopic mucosal resection (emr) procedure on (b)(6) 2019.According to the complainant, during procedure and inside the patient, the snare was inserted into the endoscope and the first polyp was strangulated.After removal, the wire was retracted inside the sheath once.When the wire was pushed out again to remove the second polyp, it was found that the snare loop got broken, so the procedure was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 fine.

Manufacturer Narrative

Block e1: the initial reporter address is (b)(6).Block h6: problem code 1069 captures the reportable event of snare loop broken.Block h10: investigation results a rotatable snare was received for analysis.Visual analysis of the returned device revealed that that the device has the loop broken.Material analysis was performed on the broken loop and as per results loop wires presented evidence of separation between sites a and b (loop fracture).Both sides were exposed to high temperature and presenting material melting.No other failure mode was identified.Based on the event description the issue occured during procedure, which most likely expose the device to high temperatures since material analysis revealed that there is evidence of material melting on the loop.The output power setting selected should remain under 50 watts, yet be as low as possible for the intended purpose.It is very important that if the proper setting of the generator is not known, one should set the unit at a power setting lower than the recommended range and cautiously increase the power until the desired effect is achieved.Based on the information available and the analysis performed, the most probable root cause classification is unintended use error caused or contributed to event, since most likely the interaction between the user and device, or sample, caused or contributed to the broken loop due to its exposure of high temperature.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: ROTATABLE SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8823403
• MDR Text Key: 152099374
• Report Number: 3005099803-2019-03479
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: 08714729283980
• Combination Product (y/n): N
• PMA/PMN Number: K160637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2022
• Device Model Number: M00561821
• Device Catalogue Number: 6182
• Device Lot Number: 0023484958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1