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

Model Number M00562341

Device Problems Failure to Cut (2587); Defective Device (2588); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the snare was not cutting through properly and was exhibiting little to no resistance when attempting to cut.This was happening with both hot and cold polypectomy.The snare was not providing a clean and smooth resection of polyps.They tried opening and closing the snare and tried it in hot and cold polypectomy.They also double checked the connection and cautery settings.Reportedly, they visually identified that the catheter seemed shorter when looking at the distal tip.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine and stable.

Manufacturer Narrative

Block h6: problem code 2587 captures the reportable event of snare loop failed to cut.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned." block h10: the device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks h2, h6 and h10 have been updated based on the investigation closure for device not returned.Correction: sections h7 and h9.

Event Description

It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the snare was not not cutting through properly and was exhibiting little to no resistance when attempting to cut.This was happening with both hot and cold polypectomy.The snare was not providing a clean and smooth resection of polyps.They tried opening and closing the snare and tried it in hot and cold polypectomy.They also double checked the connection and cautery settings.Reportedly, they visually identified that the catheter seemed shorter when looking at the distal tip.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine and stable.

• Brand Name: CAPTIVATOR
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10309501
• MDR Text Key: 200418246
• Report Number: 3005099803-2020-02851
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: 08714729019350
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2023
• Device Model Number: M00562341
• Device Catalogue Number: 6234
• Device Lot Number: 0025255681
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2759-2020
• Patient Sequence Number: 1