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

Catalog Number	AB14W060150150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/17/2019
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
It was reported that the physician was using a nanocross elite pta balloon to treat a moderately calcified, moderately tortuous, plaque 85% stenotic lesion in the distal right superficial femoral artery(sfa).There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop.The device was prepped without issue.A 6fr non-medtronic sheath with a.014 non-medtronic were used with no embolic protection.The device was inflated with a non-medtronic inflation device was used.The device did not pass through a previously deployed stent, no resistance was encountered nor excessive force used on advancing the device to the target lesion.The nanocross pta balloon ruptured and then detached during inflation to 8atm.A gooseneck snare was then used to retrieve all balloon fragments.A non-medtronic and a non-medtronic stent were used to complete the procedure successfully.No patient injury was reported.
Additional Manufacturer Narrative
The nanocross ruptured on first inflation.All device components were removed from the patient.The patient is reported to be doing fine with no injury.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation visual inspection: the nanocross elite was inspected and observed a radial balloon burst.Two balloon segments were returned, and the combined length was approximately 15cm.The distal segment showed distal marker band over the catheter shaft within the balloon.The blue catheter shaft was approximately 61.5cm (photo 9-10).The length of the gw was approximately 190 cm.Buckling of the catheter shaft was observed throughout the catheter shaft.The other balloon portion was showed a radial fracture at both ends of the balloon.No components of the delivery system were included.The proximal end of the catheter shaft which included the manifold assembly, proximal balloon bond, and proximal marker band were returned.Functional testing: the gw was attempted to be removed, however the catheter shaft continued to buckle.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Yes.

• 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: 8639688
• Report Number: 2183870-2019-00307
• Device Sequence Number: 14095030
• Product Code: LIT
• UDI-Device Identifier: 00821684067147
• UDI-Public: 00821684067147
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 08/16/2019

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: 11/28/2021
• Device Catalogue Number: AB14W060150150
• Device Lot Number: A746612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 06/07/2019; 08/15/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 07/01/2019; 08/16/2019
• 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: 68 YR
• Patient Weight: 127