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	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/16/2019
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
It was reported that the physician used a gooseneck snare in the distal right pulmonary artery.The device was inspected before use and no issues were identified.Post procedure it was noticed that the radio opaque marker had completely separated from the end of the catheter.It was reported that the device fragment remains in the patient.
Additional Manufacturer Narrative
Additional information: no resistance was encountered while advancing the device.It was reported that the catheter marker detached when the device was advanced into the pulmonary artery.The snare was not advanced through the catheter due to the detached marker.The catheter was removed from the patient no resistance encountered.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received the snare was being used to retrieve a wire.A 0.035 guidewire was being used to track to the targeted vessel anatomy in the right pulmonary artery.Analysis information: film analysis: two photographs of cine images were received for evaluation.The images show the patient¿s thoracic cavity and a radiopaque object can be observed.In the first cine image a support catheter, a couple of guidewires, and an isolated radiopaque object are visible.The isolated radiopaque object is between the patient¿s lowest rib and next to the lowest rib.In the second cine image a guidewire, inflated balloon catheter with radiopaque marker bands, and the isolated radiopaque object are visible.The isolated radiopaque object is located between the second most upper rib and the third most upper rib.Due to the quality and clarity of the photographs of the cine image it is not possible to positively identify the isolated radiopaque object as being from the goose neck snare catheter.Device analysis: the amplatz goose neck snare kit¿s catheter was received for evaluation within a sealed paper envelope that contained the goose neck snare kit opened labeled shelf carton, and the catheter loosely coiled within a zippered closure plastic pouch.No ancillary devices or additional components from the snare kit were received for evaluation.The distal tip of the goose neck snare catheter was examined and no distal tip radiopaque marker band was noted.The 6f goose neck snare catheter was examined and several kinks were noted along its 102cm +/- 1cm length.Kinks were located approximately 45.5cm, 81.2cm, and 97.0cm distal from the proximal hub.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: 8273409
• Report Number: 2183870-2019-00028
• Device Sequence Number: 167838
• Product Code: DQY
• UDI-Device Identifier: 00821684004036
• UDI-Public: 00821684004036
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/11/2019

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: 01/22/2023
• Device Catalogue Number: GN1500
• Device Lot Number: A585506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 01/25/2019; 02/18/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/18/2019; 03/11/2019
• 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: Other
• Patient Age: 8 YR
• Patient Weight: 27