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

Model Number	AB14W025150150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
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 nanocross balloon catheter along with a non-medtronic 6fr sheath and nitrex 0.014" guidewire during procedure to treat a moderately calcified lesion in the right mid posterior tibial artery (pta) and anterior tibial artery (ata) with 95% stenosis.The vessel was little tortuous.The vessel diameter and lesion length are 2.5mm and 140mm respectively.A non-medtronic inflation device was used.A 60/40 contrast/saline was used for inflation fluid.There was no damage noted to packaging.There was no issue noted when removing device from hoop/tray.The device was prepped per ifu with no issues identified.It was reported that during second balloon inflation a burst/leak/rupture occurred at 9atm.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.Another 2.5x150 nanocross was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
Additional information: no intervention needed to remove the balloon.No vessel damage and balloon was removed safely.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 balloon returned in it post inflated state.Microscopic inspection shows a slight pinch on the inner lumen just proximal to the proximal marker band.The marker bands are intact and no deformation noted.Device was unable to be flushed and a 0.014¿ guidewire from the lab was unable to be loaded which due to the pinched inner lumen adjacent to the proximal marker band, negative prep was performed, and no bubbles appear.Balloon was inflated to nominal pressure (8atm) and rated burst pressure (14atm) with no issues 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.

• Brand Name: NANOCROSS 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: 11595735
• Report Number: 2183870-2021-00121
• Device Sequence Number: 3520259
• Product Code: LIT
• UDI-Device Identifier: 00763000109707
• UDI-Public: 00763000109707
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 05/05/2021

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: 12/17/2023
• Device Model Number: AB14W025150150
• Device Catalogue Number: AB14W025150150
• Device Lot Number: B135189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 03/31/2021; 05/05/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/02/2021; 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 98