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

Catalog Number M00562670

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  malfunction  

Event Description

Sensation short throw medium 27mm snare was used during colonoscopy procedure.Snare was utilized during procedure, but would not close once it was opened.Snare was removed with no injury to patient.Fda safety report id# (b)(4).

• Brand Name: SENSATION SHORT THROW / POLYPECTOMY SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 10520811
• MDR Text Key: 206755402
• Report Number: MW5096541
• Device Sequence Number: 1
• Product Code: FDI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Catalogue Number: M00562670
• Device Lot Number: 25627673
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 53