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

Catalog Number	GN2500
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Infarction, Cerebral (1771); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to implant of a medtronic transcatheter bioprosthetic valve into a bicuspid valve.It was reported that during this procedure, the valve dislodged during the final release.The valve was snared into the ascending aorta and a second valve was implanted.The first valve was unstable in the ascending aorta and was repeatedly pulled upward with two snares.The snare became stuck and the valve was forcefully pulled to the descending aorta.The valve was attempted to be collected with a 20fr sheath in the abdominal region, but was unsuccessful.The snare and first valve were subsequently removed via laparotomy.Upon inspection, the metal tip of the medtronic snare sheath had detached, which tightened the snare tip catching the paddle of the valve.The valve was covered with thrombus and intimal tissue.The reported act (activated clotting time) levels were 250 seconds or greater throughout the procedure.Dissection was noted in the aortic arch and was monitored.The procedure was completed without further issue.One day following the procedure, a cerebral infarction occurred.Rehabilitation has been prescribed.No other adverse patient effects were reported.It has been confirmed that the device has been discarded.

• Brand Name: GOOSENECK SNARE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7272609
• Report Number: 2183870-2018-00090
• Device Sequence Number: 16173899
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2020
• Device Catalogue Number: GN2500
• Device Lot Number: A427038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Weight: 65