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

Model Number	AB14W050200150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
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 elite pta balloon along with non-medtronic 6fr sheath and 0.014" guidewire during procedure to treat a severely calcified lesion in the distal superficial femoral artery (sfa) with 90% stenosis.The vessel was had little tortuosity.The vessel diameter and lesion length are 5mm and 200mm respectively.A non-medtronic inflation device was used for balloon inflation.A 50/50 saline/contrast was the inflation fluid used.There was no damage noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepper per ifu with no issues identified.It was reported that during balloon inflation, balloon rupture occurred at 14atm.All fragments of the balloon were retrieved.The device did not pass through a previously deployed stent.There was no resistance encountered when advancing the device.The ruptured balloon was removed and a 6x100 fortrex and 5x200 evercross pta balloons were used to dilated the distal sfa.There was no patient injury.
Additional Manufacturer Narrative
Additional information: there was no vessel damage noted.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.
Additional Manufacturer Narrative
Device evaluation no damage noted to the device during visual inspection.The balloon returned in a post inflated state.Under the microscope all four marker bands were present and intact.A 10cc water filled syringe was attached to the guidewire entry port of the y-manifold and the device was flushed with no issues noted.A 0.014¿ guidewire from the lab was front loaded via the distal tip of the device and exited via the guidewire port of the y-manifold without any issues.A 10cc water filled syringe was attached to the inflation lumen luer lock of the y-manifold.The balloon chamber was inflated to approximately 8 atm, and a pinhole leak was noted in the middle section of the balloon chamber.A tear on the balloon profile is visible under a microscope.The location of the pinhole leak is proximal to the proximal middle 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 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: 11124177
• Report Number: 2183870-2021-00010
• Device Sequence Number: 14422561
• Product Code: LIT
• UDI-Device Identifier: 00763000110369
• UDI-Public: 00763000110369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132777
• 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,Followup
• Report Date (Section B): 03/11/2021

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: 03/03/2023
• Device Model Number: AB14W050200150
• Device Catalogue Number: AB14W050200150
• Device Lot Number: A986064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 01/06/2021; 03/10/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 01/08/2021; 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 73