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

Model Number	GN1000
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/04/2021
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
Physician was attempting to use nanocross pta balloon catheter along with 6fr sheath, 0.014" and spider 5.0 embolic protection during procedure to treat a severely calcified lesion in the right proximal common iliac artery and superficial femoral artery (sfa) with 70-80% stenosis.Everest inflation device was used to inflate balloon.There was no damage noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepped per ifu with no issues identified.There was balloon deflation difficulties reported, the device would not deflate at the lesion site.The vessel was pre dilated but not post dilated.The spider was unable to cross.It was reported that during attempt to remove from the vessel, the balloon detached.Damage was noted to the balloon catheter.There was no issue noted during inflation.The detached balloon was removed via open surgery.The device did not pass through a previously deployed stent.No resistance encountered when advancing the device.Physician went in with a 4.0x150 nanocross, did pta on proximal and distal sfa.After the 2nd inflation, the balloon did not fully deflate.Physician tried to remove the balloon, but it got stuck every time it reached the tip of the sheath.Physician pulled the sheath and balloon over to the left side and continued to try to pull balloon through sheath.Balloon was eventually pulled off of the shaft.Physician then tried to snare,using a gooseneck snare, the balloon from the right side but again continued to get stuck at the catheter.As a result of the balloon being stuck in the artery, physician had to do a cut down to remove.A 6fr sheath was used but later sized up to an 8fr sheath in an attempt to get the balloon out.There were 2 snares used, one medtronic and a non-medtronic.The medtronic snare actually snared the balloon but the balloon still would not come out through the catheter.It is unknown if the spider device was damaged as a result of the event and if the vessel was damaged.No further 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: 12696213
• Report Number: 2183870-2021-00388
• Device Sequence Number: 4051540
• Product Code: DQY
• UDI-Device Identifier: 00821684004029
• UDI-Public: 00821684004029
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K972511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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: 03/13/2024
• Device Model Number: GN1000
• Device Catalogue Number: GN1000
• Device Lot Number: A799141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 10/26/2021
• 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: Hospitalization; Required Intervention