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

Catalog Number	GN2500
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/01/2019
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
The physician was using a gooseneck snare for treatment.The device was prepped with no issues.It was reported that the marker band detached from the catheter while it was inside the patient.The marker band was caged to the vessel wall using a stent.No further patient symptoms or complications were reported.
Additional Manufacturer Narrative
Additional information: no resistance noted while advancing the device.There was moderate plaque present in the vessel.The snare was deployed in the superior vena cava (svc).If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation the 6f goose neck snare catheter was examined and al kink was noted along its 102cm +/- 1cm length.The kink most likely happened po st-procedure given how the device was packaged for return.The distal tip of the goose neck snare catheter was examined: no distal tip radiopaque marker band was noted.A known good snare was visually inspected side by side with the returned snare device.The presence of a radiopaque marker band was visible on the known good device.No radiopaque marker band was observed on the returned device.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: 8586001
• Report Number: 2183870-2019-00219
• Device Sequence Number: 1638788
• Product Code: DQY
• UDI-Device Identifier: 00821684004043
• UDI-Public: 00821684004043
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K970668
• 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,Followup,Followup
• Report Date (Section B): 08/12/2019

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: 10/25/2023
• Device Catalogue Number: GN2500
• Device Lot Number: A730168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 05/08/2019; 08/09/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 05/21/2019; 08/12/2019
• 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