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

Catalog Number M00562340

Device Problems Bent (1059); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2016

Event Type  malfunction  

Event Description

We were in the endoscopy room for a foreign body removal.Dr asked for a hexagonal snare to help retrieve the substance.At the start of the case the surgical tech tried to open the snare to retrieve the foreign body the snare was very difficult to open.Eventually the snare would not at open all the way.We then removed the snare from the scope assessed it, and found there was a bend in the tubing.When then decided that getting a new snare would be the best option.Boston scientific captivator medium hexagonal polypectomy snare.

• Brand Name: CAPTIVATOR
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marina bay customer fulfillment center; 500 commander shea blvd.; quincy MA 02171
• MDR Report Key: 5569472
• MDR Text Key: 42412139
• Report Number: 5569472
• 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: Patient
• Type of Report: Initial
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/19/2018
• Device Catalogue Number: M00562340
• Device Lot Number: 18520962
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1