MAUDE Adverse Event Report: COVIDIEN MICROSNARE; CATHETER, PERCUTANEOUS

Catalog Number	SK400
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: the device was received for evaluation.No ancillary devices or cine images from the procedure were received.The snare gold/tungsten hoop was received split at the hoop beak and the gold coil unwound.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a microsnare to snare an 0.014" gladius wire running retrogradly from the foot in the mid distal right sfa.The lesion was described as a 3mm diameter, moderately calcified, moderately tortuous chronic total occlusion(cto).The device was prepped as per ifu with no issues identified.Multiple attempts were performed however they were all unsuccessful.When the snare was removed from the body it was noted that the loop was broken.The snare remained intact and no fragments were broken into the patient.An alternate snare was utilized and the procedure was completed.No patient injury was reported.

• Brand Name: MICROSNARE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7420699
• Report Number: 2183870-2018-00221
• Device Sequence Number: 16155434
• Product Code: DQY
• UDI-Device Identifier: 00821684005026
• UDI-Public: 00821684005026
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K925439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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: 09/26/2022
• Device Catalogue Number: SK400
• Device Lot Number: A530469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1