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

Model Number M00562402

Device Problem Entrapment of Device (1212)

Patient Problem Tissue Damage (2104)

Event Date 06/24/2020

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 polyps 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 did not cut the tissue, but rather tore the tissue.Reportedly, the snare was securely attached to the active cord and no visible issues were noted with the cautery pins.The procedure was completed; however, it is unknown whether the original device or another captiflex snare completed the procedure.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.

Manufacturer Narrative

Block h6: problem code 1212 captures the reportable event of snare loop embedded in patient's tissue.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 captiflex medium oval flexible snare was used to treat polyps 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 did not cut the tissue, but rather tore the tissue.Reportedly, the snare was securely attached to the active cord and no visible issues were noted with the cautery pins.The procedure was completed, however, it is unknown whether the original device or another captiflex snare completed the procedure.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.

• Brand Name: CAPTIFLEX
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10295368
• MDR Text Key: 199870222
• Report Number: 3005099803-2020-02844
• 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: 07/20/2020
• 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