MAUDE Adverse Event Report: COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	AB14W030080150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photographic evaluation summary: four photographic images were received for evaluation.The first photographic image is of an electronic record screen that indicates that 14:06 a nanocross elite balloon was removed due to balloon rupture and that the balloon had been inflated up to 14atm.The other three photographic images are of cine images of the targeted vessel.Due to the quality/clarity of the photographic images of the cine images the identification of the nanocross elite and procedural ancillary devices within the images could not be made.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a nanocross pta dilatation catheter for the treatment of a severely calcified chronic total occlusion (cto) lesion in the sfa.A 6 french non-medtronic 55cm sheath and a 0.035¿ non-medtronic guidewire were used.No embolic protection was used.An unknown inflation device was used with contrast and heparinized saline.Device was prepped without issue.It was reported that a circumferential/radial balloon burst occurred at an inflation pressure of 14atms during the procedure.Device did not pass through a previously deployed stent.Resistance was encountered when advancing the device but no excessive force was used.Procedure completed by pta and stenting with 2 everflex 200mm stents.
Additional Manufacturer Narrative
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, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7012250
• Report Number: 2183870-2017-00485
• Device Sequence Number: 648677
• Product Code: DQY
• UDI-Device Identifier: 00821684066447
• UDI-Public: 00821684066447
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 12/14/2017

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: 08/13/2020
• Device Catalogue Number: AB14W030080150
• Device Lot Number: A508211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 12/15/2017
• 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: 87 YR