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

Model Number AB14W050200150

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician intended to use a nanocross elite pta balloon during treatment of a calcified cto (chronic total occlusion-100%) in the patient¿s mid right superficial femoral artery (sfa).Severe vessel calcification is reported.There was no damage noted when removing the device from the product packaging.No issues were noted when removing the device from the hoop/tray.Ifu was followed and the device was prepped without issue.The device was not passed through a previously deployed stent.No resistance was noted during advancement.Removal difficulties are reported.It is reported after inflation of the balloon to 10atm for 2 minutes, the balloon was repositioned and again inflated to 10atm.The balloon is reported to have ruptured with the balloon shaft stripping off the balloon.On attempt to remove the device, a section of the balloon separated from the catheter.Antegrade access was gained and a snare was used to retrieve the balloon in the popliteal.The patient is reported to be fine without any reported issues.No further injury re ported.

Manufacturer Narrative

Device evaluation visual inspection: the nanocross elite was returned in two fractured segments.The proximal segment showed the manifold had dried blood within the inflation lumen.A radial balloon burst was observed.The blue inner was exposed approximately 15 cm from radial fracture of the balloon.The working length of this segment was approximately 145.5cm.The second segment showed three marker bands loaded over the blue outer.The proximal end of the segment showed a ductile fracture face.The approximate length of the second segment was 26cm.The product labeling associated to lot b061991 indicate a working length 150cm.The rated burst pressure is 14 atm and nominal pressure of 8atm.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 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
• MDR Report Key: 10790980
• MDR Text Key: 214752841
• Report Number: 2183870-2020-00360
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00763000110369
• UDI-Public: 00763000110369
• Combination Product (y/n): N
• PMA/PMN Number: K132777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2023
• Device Model Number: AB14W050200150
• Device Catalogue Number: AB14W050200150
• Device Lot Number: B061991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 99