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

Catalog Number	AB14W030150150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the nanocross elite device was received for evaluation.Not all components were received.Approximately 120 mm of balloon chamber, four radiopaque marker bands, and distal tip were not returned.The device was received loaded on a 0.014¿ compatible guidewire.Approximately 30 mm of the 150 mm length balloon was received.A radial tear fracture face could be seen on the proximal balloon segment.The blue inner guidewire lumen exhibited longitudinal tensile stretching and necking down onto the 0.014¿ compatible guidewire.The inner guidewire lumen exhibited over 22 cm of longitudinal tensile stretching.Seven cine images were provided for review.The first image is of a pre-procedure contrast flow in the targeted vessel.The second image is pre-procedure of the targeted vessel.The third and fourth images are of contrast flow through the targeted vessel - a radiopaque marker band can be seen in the image proximal of the patient¿s right knee.The fifth image is of the targeted vessel - a radiopaque marker band can be seen in the image proximal to the patient¿s right knee.The distal tip of a support catheter can be seen to the right of the radiopaque marker band.The sixth image is of the targeted vessel - a radiopaque marker band can be seen in the image proximal to the patient¿s right knee.A guidewire can be seen within the targeted vessel.The seventh image is of the targeted vessel - a radiopaque marker band can be seen in the image proximal to the patient¿s right knee.A non-medtronic 5 mm x 150 mm stent can be seen implanted and covering the radiopaque marker band.The marker band can be seen located in the proximal third of the non-medtronic stent.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use a nanocross device with a non-medtronic 7fr sheath and 0.014¿ guidewire for treatment of a severely calcified 60 mm cto (chronic total occlusion-100%) lesion in the mid right popliteal artery.The vessel was described as being moderately tortuous and 4 mm in diameter.It is reported the device was prepped as per ifu without issue.During the first balloon inflation at nominal pressure (8 atms), the balloon is reported to have burst.Part of the balloon is reported to have sneered off on calcification.The physician then deployed a stent to revascularize and pin up the remaining balloon material to the vessel wall.No patient injury was reported.

• 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: 7403073
• Report Number: 2183870-2018-00211
• Device Sequence Number: 709538
• Product Code: LIT
• UDI-Device Identifier: 00821684066508
• UDI-Public: 00821684066508
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/06/2018

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: 10/01/2020
• Device Catalogue Number: AB14W030150150
• Device Lot Number: A532975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 04/06/2018
• 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: 70 YR
• Patient Weight: 77