MAUDE Adverse Event Report: COVIDIEN GOOSENECK SNARE; CATHETER, PERCUTANEOUS

Model Number	GN2500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Physician was attempting to use a gooseneck snare to capture a stretched coil in the hepatic artery.It was reported that the wire shaft of the snare device broke during the procedure.Another snare was used to complete the procedure.The procedure was delayed by less than 30 minutes.No injury to the patient was reported.
Additional Manufacturer Narrative
Additional info received: patient's approximate age is in 70's patient's approximate weight is (b)(6).
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: GOOSENECK SNARE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6248483
• Report Number: 2183870-2017-00025
• Device Sequence Number: 937191
• Product Code: DQY
• UDI-Device Identifier: 00821684004043
• UDI-Public: 00821684004043
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K970668
• 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,Followup,Followup
• Report Date (Section B): 12/15/2016

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: 08/01/2019
• Device Model Number: GN2500
• Device Catalogue Number: GN2500
• Device Lot Number: A319911
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided; 12/15/2016
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 03/14/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 60