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

Catalog Number AB14W060150150

Device Problem Burst Container or Vessel (1074)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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.

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 Description

Yes.

• Brand Name: NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8639688
• MDR Text Key: 146038503
• Report Number: 2183870-2019-00307
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00821684067147
• UDI-Public: 00821684067147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 127