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

Model Number	AB35W07040135
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
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 evercross pta balloon along with a non-medtronic 6fr sheath and 0.014" nitrex guidewire during procedure to treat a moderately calcified plaque lesion in the left proximal superficial femoral artery (sfa) with 75% stenosis.The vessel is none tortuous.The vessel diameter and lesion length are 7mm and 30mm respectively.A non-medtronic device was used for inflation.A 60 saline/40 contrast 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 balloon inflation, the balloon burst at 12atm.All fragments of the balloon were retrieved.The device passed through a previously deployed stent.Physician was post dilating a stent placed.The balloon was inflated to 12 atm when it ruptured.The balloon was then taken out and a 7 x 20 ever cross balloon was used to complete the procedure.There was no vessel damage noted.There was no patient injury.
Additional Manufacturer Narrative
Device evaluation the balloon returned in its post inflated state with lots of biologics present inside.The distal tip returned flared and damaged.Both marker bands are seen under a microscope and are intact.No damage noted to the balloon.A 20ml water filled syringe was connected to the guidewire port of the luer and the device was flushed with no issues.A 0.035¿ guidewire from the lab was loaded via the tip and exited from the gw port of the luer with no difficulty.Negative prep was performed with no issues.An indeflator was used to attempt to inflate the balloon to nominal pressure (7atm) and rated burst pressure (14atm) but was not successful.The device was soaked in a waterbath overnight, but the balloon failed to inflate.Blood residue inside the balloon profile indicated a leak/burst.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: 11575437
• Report Number: 2183870-2021-00113
• Device Sequence Number: 3622436
• Product Code: LIT
• UDI-Device Identifier: 00763000184599
• UDI-Public: 00763000184599
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• 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): 05/19/2021

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: 12/16/2023
• Device Model Number: AB35W07040135
• Device Catalogue Number: AB35W07040135
• Device Lot Number: B133884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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: 77