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

Model Number M00562652

Device Problems Entrapment of Device (1212); Failure to Cut (2587); Difficult to Open or Close (2921)

Patient Problem Tissue Damage (2104)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a sensation large oval med stiff snare was used to remove a polyp in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the technician said once the snare was introduced into the colon it became very difficult to open and close.The polyp appeared to get "stuck" in the tip of the snare while cutting and the snare would not completely close leaving the part of the tip of the snare still attached to the colon.The snare was not completely closing and it would not allow the technician to cut completely through the target polyp.When the technician tried to reopen the snare to reposition and complete the cut, the snare felt very difficult to reopen and it was not smooth when opening like it was when tested outside of the patient prior to utilization.During troubleshooting, the technician made sure that the snare was straight as she was attempting to cut and remove the snare from the scope.Reportedly, there was no visible issue noted with the handle and the snare was securely hooked to the active cord.Also, there was no visible issue noted with the cautery pins.Although the snare partly cut through the target polyp, the rest of the target polyp was removed using a biopsy forceps which completed the procedure.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be in good condition.

• 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: 10520309
• MDR Text Key: 206934297
• Report Number: 3005099803-2020-03819
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729268802
• UDI-Public: 08714729268802
• 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: Physician
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2023
• Device Model Number: M00562652
• Device Catalogue Number: 6265-20
• Device Lot Number: 0025380688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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