MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW POLYPECTOMY SNARE 13MM; SNARE, FLEXIBLE

Model Number M00562690

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2022

Event Type  malfunction  

Event Description

During colonoscopy and polypectomy, physician attempted to insert snare which worked correctly with first use and then curled up out of the gun handle rather than coming out the end with second use.Manufacturer response for snare, sensation short throw polypectomy snare 13 mm (per site reporter): equipment failure reported to the manufacturer via e-mail.Waiting on response.Product available for return to manufacturer for investigation.

• Brand Name: SENSATION SHORT THROW POLYPECTOMY SNARE 13MM
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15334559
• MDR Text Key: 299057242
• Report Number: 15334559
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562690
• Device Catalogue Number: M00562690
• Device Lot Number: 28624711
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White