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

Model Number M00562451

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) captures the reportable event of loop entrapment.(b)(4) captures the reportable event of loop failure to cut.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a captivator was used during a colonoscopy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the cautery was used at 25 watts and there was definitely a burn effect as they started, but then the snare got stuck in the polyp without cutting anymore.The nurse and doctor repositioned the scope and pushed the snare forward to try to open it again, but it was embedded in the polyp.The nurse called for assistance and they spent approximately five plus minutes trying to burn through the polyp and reposition.When they got through, there was white burned tissue and no bleeding, but a hemoclip was also used for prophylaxis.The procedure was completed with the original device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and fine.

Manufacturer Narrative

Block h6: problem code a150208 captures the reportable event of loop entrapment.Problem code a050702 captures the reportable event of loop failure to cut.Block h10: the returned captivator was analyzed, and in the visual evaluation the device was carefully inspected and no damages were found.In a functional evaluation the device was connected to the 10 inch loop fixture and the loop extended and contracted without issues.A continuity test was performed and the device passed since the device's electrical resistance was within specification, indicating a proper connection.No other issues with the device were noted.The reported issues of loop failure to cut and loop entrapment of device or device component could not be confirmed since the devices cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.Additionally, the device passed the continuity test upon return.The product record review confirmed that this is not a new failure type an the risk is anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found no issues with the device during visual, electrical, and functional tests.Based on the information available and the analysis of the returned device, this investigation is assigned the most probable conclusion code of no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a captivator was used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, the cautery was used at 25 watts and there was definitely a burn effect as they started, but then the snare got stuck in the polyp without cutting anymore.The nurse and doctor repositioned the scope and pushed the snare forward to try to open it again, but it was embedded in the polyp.The nurse called for assistance and they spent approximately five plus minutes trying to burn through the polyp and reposition.When they got through, there was white burned tissue and no bleeding, but a hemoclip was also used for prophylaxis.The procedure was completed with the original device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and fine.

• Brand Name: CAPTIVATOR
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11314183
• MDR Text Key: 231382410
• Report Number: 3005099803-2021-00442
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: 08714729071068
• Combination Product (y/n): N
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2023
• Device Model Number: M00562451
• Device Catalogue Number: 6245
• Device Lot Number: 0025761551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1