MAUDE Adverse Event Report: COVIDIEN MICROSNARE; CATHETER, PERCUTANEOUS

Catalog Number	SK700
Medical Device Problem Code	Material Distortion (2977)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using a microsnare device with a non-mdt guidewire, non-mdt 6f guiding catheter and non-mdt 6f, y adaptor, and y connector during a foreign body retrieval procedure.The device was prepped as per ifu without issue.It was reported that when the physician began to insert the device, the snare wire coating was observed to be partially peeled and difficulty was experienced when attempting to insert.The device was replaced with a new microsnare to complete the procedure without further issue.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: 7376643
• Report Number: 2183870-2018-00187
• Device Sequence Number: 16364489
• Product Code: DQY
• UDI-Device Identifier: 00821684005033
• UDI-Public: 00821684005033
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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: 07/18/2021
• Device Catalogue Number: SK700
• Device Lot Number: A312521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1