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

Catalog Number	AB14W050100150
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/21/2019
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
The physician was intending to use a nanocross elite to treat a 100mm calcified plaque lesion with 90% stenosis in the left proximal superficial femoral artery (sfa).Artery diameter of 5mm.A 7fr non-medtronic sheath and a 5mm spiderfx was used in the procedure.There was no damage to the device packaging and no issues when removing the device from its packaging.The device was prepped per ifu with no issues.The device did not pass through a previously deployed stent and excessive force was not used.The balloon was initially inflated using a non medtronic inflation device with isovue 370 heparinized saline fluid.It was reported that balloon deflation difficulties were encountered and the device would not deflate at the lesion site.The balloon was deflated using a wire puncture technique through the balloon lumen.The deflated balloon was removed from the patient.No patient injury was reported.
Additional Manufacturer Narrative
Image review: two photographs were received.The first image is of a cine image with the nanocross elite dilatation catheter inflated in the targeted vessel anatomy, the left proximal superficial femoral artery.The second image is of the nanocross elite shelf carton.Product analysis: the nanocross dilatation catheter was received for evaluation.No ancillary devices or cine images from the procedure were received for evaluation.The proximal end of the balloon chamber was examined: the proximal end of the balloon chamber has been crimped.The crimping of the proximal balloon bond would reduce the inflation lumen cross section and affect deflation rate of the balloon.The customer experience of a nanocross elite dilatation catheter being unable to deflate was confirmed.The returned nanocross elite dilatation catheter exhibited crimping of the proximal balloon bond.The crimp marks would reduce the inflation pathway inside diameter profile.The reduction of the inflation pathway inside diameter profile would affect the device¿s performance to deflate.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: 8543480
• Report Number: 2183870-2019-00181
• Device Sequence Number: 367971
• Product Code: LIT
• UDI-Device Identifier: 00763000110307
• UDI-Public: 00763000110307
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 05/22/2019

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: 02/05/2022
• Device Catalogue Number: AB14W050100150
• Device Lot Number: A778632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 04/21/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/22/2019
• 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: 59 YR