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

Catalog Number	GN1500
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the goose neck snare was received for evaluation.The snare device was returned with the snare wire inserted within the catheter lumen.No ancillary devices, cine, images or procedure notes were returned for evaluation the snare wire was observed to be damaged.Visual inspection under magnification reveal the snare wire jacket was torn and exposing the bare metal.The catheter was examined: visual inspection of the catheter reveal a tip damage.The radiopaque marker was not present.The catheter total working length was measured to approximately 94cm from the catheter hub.Per the product label specification associated with lot a790702, the catheter working length is 102cm from the catheter hub.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the amplatz goose neck snare was prepared as per ifu.The catheter was used as intended however, the device became damaged during the procedure.Another snare of the same specification was used to complete the procedure.There was no patient injury reported.

• Brand Name: GOOSENECK SNARE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8933792
• Report Number: 2183870-2019-00418
• Device Sequence Number: 1902425
• Product Code: DQY
• UDI-Device Identifier: 00821684004036
• UDI-Public: 00821684004036
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 08/27/2019

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: 02/27/2024
• Device Catalogue Number: GN1500
• Device Lot Number: A790702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1