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

Catalog Number	AB14W020080150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2018
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
Physician used a nanocross balloon during treatment of a plaque lesion in the patients mid anterior tibial artery.Slight calcification reported.Ifu was followed and the device was prepped without issue.It is reported that during first balloon inflation the balloon burst (longitudinally) at an unknown pressure which was below rbp.No balloon fragments remained in the patient and the procedure was completed using a new nanocross balloon.No patient injury reported.
Additional Manufacturer Narrative
Evaluation summary: the nanocross elite 0.014in over-the-wire pta balloon dilatation catheter was received for evaluation loaded within its protective transportation hoop.No ancillary devices or cine images from the procedure were received for evaluation.The nanocross elite was received with the balloon chamber in a post-inflated state.A 0.014¿ guidewire was loaded with ease through the distal tip and navigated out the proximal luer lock with ease.A 10cc water filled syringe was attached to the inflation lumen luer lock on the y-manifold, a vacuum was able to be pulled and held.A 20cc water filled syringe with manometer was attached to the y-manifold inflation lumen luer lock and the balloon chamber was able to be inflated to nominal pressure of 8 atm; no leaks were detected.The pressure within the dilatation catheter was increased to its rated burst pressure of 14 atm; no leaks were detected.The returned nanocross dilatation catheter exhibited no leaks or ruptures and could hold rated burst pressure.If information is provided in the future, a supplemental report will be issued.

• 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: 7933768
• Report Number: 2183870-2018-00457
• Device Sequence Number: 1665413
• Product Code: LIT
• UDI-Device Identifier: 00821684066126
• UDI-Public: 00821684066126
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K132777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2018

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: 08/31/2020
• Device Catalogue Number: AB14W020080150
• Device Lot Number: A517795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1