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

Catalog Number	AB14W060100150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
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
The physician was attempting to use a nanocross elite to treat a severely calcified lesion in the proximal superficial femoral artery (sfa).No embolic protection was used.A non medtronic inflation device was used to inflate the device.The ifu was prepped with no issues reported.There was no damage to the device or the packaging.The device passed through a previously deployed stent.No resistance was encountered and no excessive force used.It was reported that a balloon burst occurred when the device was inflated to 8 atm.Another nanacross device 6x150 was used and also burst when inflated to 8atm (nominal pressure) at an area just below where the first balloon burst.All fragments of the balloons were retrieved.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: a 6fr sheath and a non-medtronic guidewire were used in the procedure.Contrast fluid was used to inflate the balloon and negative prep was performed.A nanocross balloon was used to complete the procedure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 8248393
• Report Number: 2183870-2019-00021
• Device Sequence Number: 1582748
• Product Code: LIT
• UDI-Device Identifier: 00821684067109
• UDI-Public: 00821684067109
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 04/04/2019

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: 09/09/2021
• Device Catalogue Number: AB14W060100150
• Device Lot Number: A704716
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/29/2019; 04/03/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/15/2019; 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1