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

Model Number M00562402

Device Problems Electrical /Electronic Property Problem (1198); Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Perforation (2001); No Code Available (3191)

Event Date 06/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 captiflex medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the device failed to cut the target polyp using cautery.Reportedly, the physician had to "over burn" to remove the polyp which caused a transmural burn.The original device was used to complete the colonoscopy procedure.On (b)(6) 2020, it was confirmed through computerised tomography scan (ct scan) that the patient had a micro perforation.An ostomy bag was inserted as a result of irritation from the micro-perforation.It is expected that the ostomy bag will be reversed after 3 months.Reportedly, the patient had no comorbidities.The patient was admitted to the hospital for at least a week and is expected to fully recover.

Event Description

It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the device failed to cut the target polyp using cautery.Reportedly, the physician had to "over burn" to remove the polyp which caused a transmural burn.The original device was used to complete the colonoscopy procedure.On (b)(6) 2020, it was confirmed through computerised tomography scan (ct scan) that the patient had a micro perforation.An ostomy bag was inserted as a result of irritation from the micro-perforation.It is expected that the ostomy bag will be reversed after 3 months.Reportedly, the patient had no comorbidities.The patient was admitted to the hospital for at least a week and is expected to fully recover.

Manufacturer Narrative

Block h6: problem code 2587 captures the reportable event of snare loop failure to cut.Problem code 1198 captures the reportable event of suboptimal cautery.Problem code 2001 captures the reportable event of perforation.Problem code 1757 captures the reportable event of burns.Problem code 3191 captures the reportable event of ostomy procedure.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.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.Block h11: blocks h2, h6 and h10 have been updated based on the investigation closure for device not returned.Correction: sections h7 and h9.

• Brand Name: CAPTIFLEX
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10311023
• MDR Text Key: 199986665
• Report Number: 3005099803-2020-02891
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501640
• UDI-Public: 08714729501640
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Model Number: M00562402
• Device Catalogue Number: 6240-40
• Device Lot Number: 0025133479
• 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
• Patient Outcome(s): Hospitalization; Required Intervention