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

Model Number M00562673

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to boston scientific corporation that a sensation medium oval flexible snare was used to remove a less than 1 cm 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 snare would not cut through the less than 1 cm target polyp smoothly due to the resistance felt when actuating during both hot and cold polypectomy.There was no tactile feedback according to the nurse/tech.They checked the cautery settings, opened and closed the snares as a test to ensure they were functioning properly.They also made sure that the cautery port was connected securely to the snares and tried both hot and cold.Reportedly, no visible issues was noted with the handle.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine and stable.

• 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: 10302575
• MDR Text Key: 199882671
• Report Number: 3005099803-2020-02846
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501664
• UDI-Public: 08714729501664
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: M00562673
• Device Catalogue Number: 6267-40
• Device Lot Number: 0025396338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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