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

Model Number M00562400

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2016

Event Type  malfunction  

Event Description

Attempt to remove a foreign body (piece of steak) from the patient.After much squeezing and pushing with the handle to pull the steak that the wires on the device bent (used two devices and both bent).Manufacturer response for captiflex, single-use polypectomy snare (per site reporter): gave an ra# to return the device.

• Brand Name: CAPTIFLEX
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 500 commander shea blvd; quincy MA 02171
• MDR Report Key: 5662252
• MDR Text Key: 45377162
• Report Number: 5662252
• 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: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/04/2019
• Device Model Number: M00562400
• Device Lot Number: 18764564
• Other Device ID Number: 0871472974932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR