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

Model Number M00562402

Device Problem Failure to Cut (2587)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2020

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 captiflex medium oval flexible snare was used to treat a target polyp during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, after cautery was applied with polypectomy, the device did not completely cut through the tissue leaving a much longer cautery time/area than physician deemed necessary.The physician then applied hemo clips as a precaution to ensure that there was no perforation.It was reported that the patient is expected to fully recover.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used to treat a target polyp during a colonoscopy procedure performed on (b)(6), 2020.According to the complainant, during the procedure, after cautery was applied with polypectomy, the device did not completely cut through the tissue leaving a much longer cautery time/area than physician deemed necessary.The physician then applied hemo clips as a precaution to ensure that there was no perforation.It was reported that the patient is expected to fully recover.***additional information received on (b)(6) 2020*** the snare was securely attached to the active cord and there were no visible issues noted with the cautery pin.No other issues were noted with the device.It was reported that the patient did not have a true and complete perforation.In addition, the patient's tissue was not friable and the patient did not undergo chemotherapy or radiation treatment.The procedure was reported to be completed with a different size snare but the hospital could not confirm which specific snare was used.The patient's condition at the conclusion of the procedure was reported to be 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: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.Block h11: blocks b5, d8, f10 and h6 (patient codes), h2 and h10 have been updated based on the additional information received on (b)(6) 2020.

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: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used to treat a target polyp during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, after cautery was applied with polypectomy, the device did not completely cut through the tissue leaving a much longer cautery time / area than physician deemed necessary.The physician then applied hemo clips as a precaution to ensure that there was no perforation.It was reported that the patient is expected to fully recover.Additional information received on july 22, 2020: the snare was securely attached to the active cord and there were no visible issues noted with the cautery pin.No other issues were noted with the device.It was reported that the patient did not have a true and complete perforation.In addition, the patient's tissue was not friable and the patient did not undergo chemotherapy or radiation treatment.The procedure was reported to be completed with a different size snare but the hospital could not confirm which specific snare was used.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: CAPTIFLEX
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10271733
• MDR Text Key: 199696381
• Report Number: 3005099803-2020-02729
• 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,Followup
• Report Date: 10/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: M00562402
• Device Catalogue Number: 6240-40
• Device Lot Number: 0025142120
• 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