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

Catalog Number M00562690

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Date 05/04/2017

Event Type  malfunction  

Event Description

During colonoscopy, physician was snaring multiple polyps using the snare.While attempting to snare another polyp with snare, the snare would not come out of sheath further than approximately 3/4 inch.A new snare was obtained and used for the remainder of the procedure without problem.

• Brand Name: SENSATION
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6788152
• MDR Text Key: 82488553
• Report Number: 6788152
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2017,07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/05/2020
• Device Catalogue Number: M00562690
• Device Lot Number: 20124894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; OLYMPUS COLONSCOPE
• Patient Age: 65 YR
• Patient Weight: 100