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

Model Number M00561291

Device Problems Entrapment of Device (1212); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date of (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a captivator extra large round stiff snare was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the snare cauterized the target polyp.However, it would not cut through the mucosa and the snare loop was embedded in the patient's tissue.They had difficulty trying to remove the snare so they cut the device at the handle with wire cutters.The scope was then removed over the snare and placed the scope back at the location of the snare site.Using biopsy forceps, they were able to remove the snare by pulling on it in portions.The procedure was then completed using another captivator snare.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: CAPTIVATOR II
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9459169
• MDR Text Key: 175233644
• Report Number: 3005099803-2019-05939
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: 08714729645801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2021
• Device Model Number: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0021759767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention