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

Model Number M00562321

Device Problems Retraction Problem (1536); Failure to Cut (2587)

Patient Problem Burn(s) (1757)

Event Date 02/27/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a captivator medium oval stiff snare was used to remove polyps in the colon during an unknown procedure performed on (b)(6) 2022.During the procedure and inside the patient, the device could not be closed and the device was unable to completely cut off the target polyp during treatment, "resulting in excessive burns of the surrounding intestinal mucosa and easy infection." the procedure was completed with another captivator snare.The burns were resolved by using clips.There was no reported infection, it was reported that the physician used the clip to prevent infection.There were no further patient complications reported as a result of this event.

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The reported healthcare facility is: (b)(6).Phone number: (b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 14287931
• MDR Text Key: 290780579
• Report Number: 3005099803-2022-02267
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: 08714729019336
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2022
• Device Model Number: M00562321
• Device Catalogue Number: 6232
• Device Lot Number: 0024739585
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2019
• 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