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

Catalog Number	AB14W030210150
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	02/28/2018
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
It was reported that the physician was using a nanocross device with a 6fr sheath and 0.014 guidewire for the treatment of a 250 mm moderately calcified lesion in the distal/mid right superficial femoral artery/posterior tibial artery of diameter 3.0 mm.Lesion exhibited 70% stenosis.Vessel described as being slightly tortuous.Embolic protection was not used.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device nor was excessive force used.An inflation device was used with saline and contrast for inflation.Device was prepped as per ifu without issue.It is reported there were difficulties experienced when the physician attempted to remove the balloon post inflation.It is reported the catheter was removed with a gooseneck snare but a portion of the balloon had torn away from the catheter.The physician successfully pulled the balloon fragments out of the posterior tibial artery into the superficial femoral artery.However, he was unable to be pull the balloon through the sheath.The physician decided to deploy a stent to tack the balloon material to the vessel wall.Following deployment of the stent there was brisk flow and no flow limiting deformities visualized.

• 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: 7377412
• Report Number: 2183870-2018-00190
• Device Sequence Number: 19175747
• Product Code: LIT
• UDI-Device Identifier: 00821684066522
• UDI-Public: 00821684066522
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 03/28/2018

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: 01/22/2021
• Device Catalogue Number: AB14W030210150
• Device Lot Number: A585824
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/28/2018
• 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: 60 YR
• Patient Weight: 100