MAUDE Adverse Event Report: COVIDIEN MICROSNARE; CATHETER, PERCUTANEOUS

Model Number	SK400
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gooseneck snare was returned for evaluation loosely within a clear bag.The catheter and the snare wire were returned in separate bags.The components were removed from their respective packaging for additional analysis.Visual inspection of the catheter reveal a damage distal tip.Under magnification, the distal tip appeared to be flared and cut marks were observe on the tip edges.The snare wire exhibited multiple twist proximal to the hoop.Visual of the snare wire hoop appeared to be stretched and gold winding unraveled.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use a micro snare during procedure.The device was prepped per ifu with no issues identified.The vessel was moderately tortuous.The microsnare was not used to snare a medtronic device.The snare was extended during the procedure.The device broke during traction when hooking the guidewire, which was advanced from retrograde of below-knee artery.The physician reported that the snare was extended during the procedure, one side of the joint part of snare annulus was broken reportedly when confirming the detailed information.Since it was a broken issue of one side of the joint part of annulus, nothing detached and nothing remained inside the patient's body.The device was safely removed from the patient by being pulled in the parent non-medtronic sheath and was retrieved.There was no vessel damage reported.After the snare was retracted, the procedure was completed using a non medtronic snare.There was no patient injury reported.

• Brand Name: MICROSNARE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10262929
• Report Number: 2183870-2020-00218
• Device Sequence Number: 3462824
• Product Code: DQY
• UDI-Device Identifier: 00821684005026
• UDI-Public: 00821684005026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K925439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2025
• Device Model Number: SK400
• Device Catalogue Number: SK400
• Device Lot Number: A983992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1