MAUDE Adverse Event Report: COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	AB14W040100150
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/21/2018
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 intended to use the nanocross balloon with a 6f non-medtronic sheath and a nitrex 014 guidewire to treat a severely calcified lesion with 85%stenosis in the popliteal, tibial/popliteal trunk and anterior tibial artery.Artery diameter 4mm, lesion length 100mm.The device was prepped as per ifu with no issues identified.The device did not pass through a previously deployed stent, no resistance or excessive force was used.It was reported the during first inflation the balloon burst radially at 3atms.The catheter was removed from the patient.The balloon was removed from the patient in pieces and the distal portion of the balloon could not be removed and remains in the anterior tibial artery opposed to the vessel wall.The procedure was completed at this point.
Additional Manufacturer Narrative
Image analysis: the nanocross elite 0.01¿ over-the-wire pta balloon dilatation catheter was not received for evaluation.No ancillary devices or procedural reports from the procedure were received for evaluation.Two cine images from the procedure were received.The first cine image is of the targeted vessel prior to treatment.The vessel is severely calcified.The second image is of the targeted vessel with procedural devices in the vessel.A support sheath and guidewire are visible in the image.Three radiopaque marker bands are visible on the guidewire in the image.Due to the quality and clarity of the image it is not possible to positively identify if two of the marker bands are of the nanocross elite 100mm length balloon.Due to the quality and clarity of the image it is not possible to positively determine if the nanocross elite 100mm length balloon experienced a radial burst.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NANOCROSS 0.14 OTW PTA DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8127959
• Report Number: 2183870-2018-00559
• Device Sequence Number: 11151195
• Product Code: LIT
• UDI-Device Identifier: 00821684066782
• UDI-Public: 00821684066782
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082854
• 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
• Report Date (Section B): 01/14/2019

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: 07/23/2021
• Device Catalogue Number: AB14W040100150
• Device Lot Number: A680733
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/14/2019
• 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
• Patient Age: 84 YR