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

Model Number AB14W040150150

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician attempted to use a nanocross device with a 7f sheath and a non-medtronic guide wire to treat a calcified lesion in a patients proximal superficial femoral artery and distal popliteal artery.Little degree of tortuosity and severe calcification were reported.There was no damage noted to packaging and there were no issues noted when removing from the hoop/tray.The device was prepped as per ifu with no issues noted.There was no resistance felt when advancing the device and no excessive force was used.During balloon inflation the balloon burst.8 atms was applied to the balloon prior to burst.It was reported that the type of balloon burst was circumferential/radial.No balloon fragments remained in the patient.The procedure was completed by using another pta balloon.There was no injury to the patient.

Manufacturer Narrative

Product analysis: the nanocross device was returned to medtronic investigation lab for evaluation.Also returned with the device was the label card which indicated that the returned device was a 4.0mm nanocross elite.No ancillary devices or images returned for evaluation.The returned device was a 4.0 x 150mm.Nanocross elite catheter.A red blood-like substance was noted within the y-manifold, catheter, and balloon chamber.The balloon was received in a post-inflation profile.Inspection of the device revealed that the blue inner guide wire lumen was outside of the outer assembly/balloon.A 10cc syringe was attached to the proximal hub and the guide wire lumen was flushed, a red liquid, consistent with blood was observed exiting the lumen.A 0.014¿ guide wire was then loaded through the lumen, no resistance was encountered during advancement of the guide wire.The 10cc syringe was then attached to the inflation port of the manifold and the balloon chamber was inflated.The proximal initiation point of the longitudinal tear was noted during inflation.The tear initiated approximately 11.3cm proximal to the catheters distal tip and continued to the end of the balloon assembly.The balloon was flushed/cleaned, and the tear was inspected microscopically.It was noted that the distal bond remained intact.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: NANOCROSS 0.14 OTW PTA DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9615504
• MDR Text Key: 198755653
• Report Number: 2183870-2020-00024
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000110185
• UDI-Public: 00763000110185
• Combination Product (y/n): N
• PMA/PMN Number: K082854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: AB14W040150150
• Device Catalogue Number: AB14W040150150
• Device Lot Number: A923048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR