MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIFLEX MEDIUM OVAL FLEXIBLE SINGLE USE POLYPECTOMY SNARE; SNARE, FLEXIBLE

Catalog Number M00562402

Device Problem Defective Device (2588)

Patient Problems Abdominal Pain (1685); Pain (1994); Perforation (2001); Burn, Thermal (2530)

Event Date 06/26/2020

Event Type  Injury  

Event Description

Patient scheduled for routine colonoscopy.Had a flat polyp at the cecum that was removed via hot snare.Snare malfunctioned and physician had to increase the strength of the cautery in order to remove polyp.Patient was admitted to hospital with abdominal pain and was diagnosed with a thermal burn.Patient had continue pain over the next several days, had another ct scan which showed a perforation.Patient had surgery with the placement of a temporary colostomy bag.Fda safety report id# (b)(4).

• Brand Name: CAPTIFLEX MEDIUM OVAL FLEXIBLE SINGLE USE POLYPECTOMY SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; malborough MA 01752
• MDR Report Key: 10282948
• MDR Text Key: 199304871
• Report Number: MW5095553
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501640
• UDI-Public: (01)08714729501640(17)230129(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Catalogue Number: M00562402
• Device Lot Number: 25133479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• 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 Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 77