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

Catalog Number	AB14W030210150
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: the nanocross elite was returned for evaluation.The 0.014¿ guidewire was retuned not loaded the catheter.A bend to the guidewire was noted approximately 91cm from one of the ends of the guidewire.A piece of the nanocross elite was inspected.It was the distal end with the balloon.Dried biologics were noted within and outside of the balloon segment.The approximate length was 20cm.Four pieces of the blue inner with frayed ends were inspected.The inner fracture faces were ductile.Curling of the blue inner assemblies which were damaged was noted.One segment showed a flat fracture face, the other ends of the blue fractured pieces showed frayed ends consistent with being subjected to longitudinal tensile forces.The proximal end of the catheter was approximately 127 long (working length).With a radial fracture at the distal end.No trace of the blue inner assembly was noted.The outer clear assembly was visible with biological debris within the lumen.It should be noted the combined length of the distal (balloon assembly) and proximal segment (catheter shaft) was 147cm.The product labeling indicates the working length is 150cm.The catheter fracture occurred at the proximal balloon bond.The distal end was soaked in water in effort to dissolve biologics that impact the ability to view the marker bands and inner assembly.Biological debris remained; however the inner assembly was more visible.The distal marker band was identified; however no other marking bands could be identified.The approximate length of the blue inner assembly within the balloon segment was 14cm.
Event or Problem Description
The physician was attempting to use a nanocross elite pta balloon to treat a 300 mm lesion with little calcification in the distal right anterior tibial artery.The artery was 3 mm in diameter and had 60% stenosis.The procedure used a 6 fr non-medtronic sheath and a 0.014" non-medtronic guidewire.The nanocross balloon was prepped as per the ifu with no issues identified.The device was inflated using 50/50 inflation fluid.The physician experienced no resistance advancing the device and it did not pass through a previously deployed stent.It was reported that during removal of the balloon, the inside of the balloon (blue inner lining) became stuck on wire and was pulled out leaving the balloon with no stiffness behind.The balloon was removed using a gooseneck snare.The procedure was completed using another nanocross device.No patient injury was reported.

• Brand Name: NANOCROSS ELITE 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: 7051875
• Report Number: 2183870-2017-00520
• Device Sequence Number: 903286
• Product Code: LIT
• UDI-Device Identifier: 00821684066522
• UDI-Public: 00821684066522
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132777
• 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
• Report Date (Section B): 11/21/2017

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: 08/13/2020
• Device Catalogue Number: AB14W030210150
• Device Lot Number: A507632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/22/2017
• 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