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

Model Number M00562400

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 09/15/2017

Event Type  malfunction  

Event Description

Cautery snare placed around patient bronchial tumor, foot pedal stepped on, but cautery wouldn't work.Replaced everything in the cautery loop and still wouldn't work.Finally got the snare off the tumor and replaced snare, and the replacement snare worked.Small amount of unneeded bleeding occurred because of snare malfunction and extended stress placed on tumor while not being cauterized.

• Brand Name: CAPTIFLEX
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6893179
• MDR Text Key: 87350267
• Report Number: 6893179
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2017,09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/21/2019
• Device Model Number: M00562400
• Device Lot Number: 18945550
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR