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

Model Number	AB35W06120135
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
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 an evercross pta balloon during procedure to treat a severely calcified lesion in the superficial fe moral artery (sfa).There was no damage noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepped per ifu with no issues identified.There was difficulty removing balloon following balloon inflation.The device did not pass through a previously deployed stent.There was resistance encountered when advancing the device.It was reported that balloon got ruptured in sfa, half of the balloon got stuck due to the calcium in the vessel, two physicians tried to snare it out, but was unsuccessful.Finally contrast run was done and patient had good flow, for that reason, physician did not bypass the patient.Patient was sent to another hospital to keep an eye on as no vascular surgeon was on call at the treatment facility.Physician did not do any datix on this incident, as this was not an avoidable incident due to calcium, balloon got stuck.No further patient injury reported.
Additional Manufacturer Narrative
Device evaluation visual inspection confirms a detachment on the balloon at approx.85mm distal from the proximal balloon bond.Biologics are present inside the balloon.Under the microscope, the proximal balloon marker band is visible and intact.The detachment site on the balloon is visible and the remaining portion of the balloon did not return for analysis.The detachment site of the inner lumen is also visible with flared edges.No functional testing could be carried out as a result of the returned state of the device.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: 11445791
• Report Number: 2183870-2021-00088
• Device Sequence Number: 19612345
• Product Code: LIT
• UDI-Device Identifier: 00763000184476
• UDI-Public: 00763000184476
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: AB35W06120135
• Device Catalogue Number: AB35W06120135
• Device Lot Number: B018411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention