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

Model Number M00562371

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bowel Perforation (2668); No Code Available (3191)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over age of 18.The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any relevant information is received, a supplement mdr will be filed.

Event Description

It was reported to boston scientific corporation that a captivator medium crescent snare was used in the colon during a colonoscopy with polypectomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician was performing polypectomy.While lifting the polyp with orise gel and resecting the target polyp it was noted through visual endoscopy that there was a perforation in the colon.Reportedly, the patient did not present any symptoms.However, the patient's tissue was friable.There was no alleged malfunction nor any damage noted with the device.In the physician's assessment, the snare did not cause or contribute to the perforation; however, it was the thin wall or heat that caused the perforation.The perforation was treated through surgical intervention and was resolved.The procedure was not completed due to this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: CAPTIVATOR
• 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: 9305803
• MDR Text Key: 166149685
• Report Number: 3005099803-2019-05495
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019381
• UDI-Public: 08714729019381
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00562371
• Device Catalogue Number: 6237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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