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

Model Number	AB14W025210150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use a nanocross pta balloon catheter along with non-medtronic 5fr sheath and 0.014"guidewire during procedure to treat a little calcified plaque lesion in the right mid pedal artery with 80% stenosis.The vessel was little tortuous.The vessel diameter and lesion length are 2.5mm and 200mm respectively.No embolic protection was used.A non-medtronic inflation device was used for balloon inflation.Contrast was used for inflation fluid.There was no damage noted to packaging.There was no issue noted when removing the device from the hoop/tray.The device was prepped per ifu with no issues identified.It was reported that during balloon inflation, it burst at 10atm during the second inflation.No intervention was needed to remove fragments from patient.No vessel injury occurred.The device was safely removed from patient.The device passed through a previously deployed stent.There was no resistance encountered when advancing the device.The procedure was completed with another balloon and no other issues occurred.There was no patient injury.
Additional Manufacturer Narrative
Device evaluation the balloon returned in its post inflated state.Biologics are visible inside the balloon and catheter lumen.Visual inspection under a microscope shows all marker bands are visible and intact.A 20ml water filled syringe was connected to the device and flushed with no issues.Negative prep was performed, and bubbles were noted entering the syringe which indicates a leak/burst.A 0.014¿ guidewire from the lab was front loaded via the distal tip and exited out the gw port of the luer with no issues.The balloon was attempted to be inflated using a pressure gauge and indeflator.A burst was noted immediately coming from the balloon.The burst location was measured under a microscope and is approx.3.4cm distal from the proximal marker band.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
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 12511573
• Report Number: 2183870-2021-00345
• Device Sequence Number: 11038011
• Product Code: LIT
• UDI-Device Identifier: 00763000109721
• UDI-Public: 00763000109721
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K082854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2024
• Device Model Number: AB14W025210150
• Device Catalogue Number: AB14W025210150
• Device Lot Number: B212829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 100