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

Model Number M00562671

Device Problems Entrapment of Device (1212); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect devices has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to one of five devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-03955, 3005099803-2020-03956, 3005099803-2020-03957, 3005099803-2020-03959 for the associated device information.It was reported to boston scientific corporation that a total of five sensation medium oval flexible snares were used to remove polyps in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, when the snare was used to cut through the target polyp, the snare got caught on the tissue.There was no resistance and the snare would not cut through.There were no signs of blanching (tissue turning white).During troubleshooting, the cautery was reattached and the snare was securely attached to the active cord.Reportedly, there was no visible issue noted with the cautery pin and no other issues were noted with the five devices.The procedure was completed with another sensation snare.There was no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.

• Brand Name: SENSATION SHORT THROW
• Type of Device: 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: 10543256
• MDR Text Key: 207228433
• Report Number: 3005099803-2020-03960
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729158141
• UDI-Public: 08714729158141
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: M00562671
• Device Catalogue Number: 6267
• Device Lot Number: 0025508443
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1