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

Catalog Number	AB14W040080150
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
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 attempting to use a nanocross to treat a severely calcified cto (chronic total occlusion) lesion in the mid left superficial femoral artery(sfa).The artery diameter and lesion length were 6mm and 350mm respectively.Physician used a non-medtronic 6fr 11cm sheath, a non-medtronic guidewire and a non-medtronic inflation device.50/50 saline/contrast mixture was used.The ifu was followed and the device was prepped without issue.The device passed through a previously deployed stent.Resistance was reported when advancing the device.Excessive force was used during delivery and withdrawal.It was reported that the physician had difficulty advancing the balloon through the deployed stent as the artery was heavily calcified.After inflating the balloon in the stent, to open up the artery, the calcified vessel recoiled and applied pressure to the balloon making it difficult to withdraw from the stented area and the patient.The physician applied force in an attempt to remove the balloon catheter, it came free but was hard to pull into the sheath.Additional force was applied, the balloon catheter came out but was lodged in the distal end of the sheath.When the sheath was removed from the patient the balloon came out with the sheath and was removed from the patient.Hemostasis was achieved and the patient experienced no adverse outcome due to the balloon dislodgment from the catheter.

• 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: 8063590
• Report Number: 2183870-2018-00510
• Device Sequence Number: 13988606
• Product Code: LIT
• UDI-Device Identifier: 00821684066768
• UDI-Public: 00821684066768
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2020
• Device Catalogue Number: AB14W040080150
• Device Lot Number: A449038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR