MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	AB35W06040135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
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 attempted to use an evercross pta balloon with a spider fx and 7fr non-medtronic sheath, during treatment of a 40mm calcified lesion in the patient¿s proximal and distal left superficial femoral artery (sfa) and common iliac artery.Artery diameter reported as 6mm.Slight vessel tortuosity and moderate calcification reported.Lesion exhibited 75% stenosis.A non-medtronic inflation device was used with saline and contrast for balloon inflation.There was no damage noted to the device packaging.No issues were noted during removal of the device from the hoop/tray.Ifu was followed and the device was prepped without issue.The distal portion of the balloon was in a previously deployed stent (implanted greater than 1 year ago).Resistance was noted during advancement, but no excessive force was used.The physician attributed the advancement difficulty to be due to using a 0.035 balloon over a 0.014 wire.Resistance was not felt in relation to advancement into stent but in proximal segment of distal external iliac/common femoral artery.It is reported during first inflation the balloon burst at 6atm.The balloon was replaced to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Additional information: the device was safely removed from patient.No intervention required to remove device.All components of device were retrieved.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation visual inspection of balloon shows biologics present inside the balloon.A 20ml water filled syringe was used to flush the device and a steady stream of water was observed exiting the tip.A 0.035¿ guidewire from the lab was front loaded via the tip and exited out of the gw port of the luer with no difficulty.Negative prep performed and no bubbles noted.During balloon inflation a pinhole leak was noted immediately just distal to 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: EVERCROSS 035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 11618681
• Report Number: 2183870-2021-00128
• Device Sequence Number: 4009838
• Product Code: LIT
• UDI-Device Identifier: 00763000184377
• UDI-Public: 00763000184377
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K082579
• 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: 11/11/2023
• Device Model Number: AB35W06040135
• Device Catalogue Number: AB35W06040135
• Device Lot Number: B116322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 04/07/2021; 05/05/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 04/15/2021; 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: 76