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

Model Number	AB35W05150135
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/20/2021
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 the evercross pta balloon during procedure to treat moderately calcified lesion in the distal mid pr oximal right superficial femoral artery (sfa).The vessel had moderate tortuosity and cto (chronic total occlusion-100%).The artery diameter was 5mm and lesion length was 25cm.Non-medtronic 6fr 45cm sheath and 45cm guidewire were used.No embolic protection was used.The balloon was inflated with a non-medtronic inflation device.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.Ifu was followed.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device but no excessive force used.It was reported that there were balloon deflation difficulties and device would not deflate at the lesion site.Deflation issues noted during subsequent inflation.The evercross 5 x 150 was inserted over a non-medtronic guidewire 0.035'' wire to treat long sfa cto.Initially inflated to 2 atm with no issues.After second inflation the balloon would not deflate.They tried negative, unhooked inflation device but could not deflate.They used 0.014'' wire to pop balloon but were unsuccessful.The procedure was completed by pulling out the balloon, wire and sheath and using a new balloon, wire and sheath with no issues.No patient injury.
Additional Manufacturer Narrative
Additional information: no damage noted to balloon catheter.They used 0.014'' non-medtronic wire to pop balloon but were unsuccessful.Balloon deflated a little bit and was able to be pulled back into iliacs.Then balloon and sheath was pulled out in tandem.Unknown how long the partial deflation took.Negative prep with syringe was used eventually for deflation.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, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 12679373
• Report Number: 2183870-2021-00386
• Device Sequence Number: 1364203
• Product Code: LIT
• UDI-Device Identifier: 00763000184278
• UDI-Public: 00763000184278
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 11/01/2021

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: 06/20/2024
• Device Model Number: AB35W05150135
• Device Catalogue Number: AB35W05150135
• Device Lot Number: B223948
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 10/24/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 11/01/2021
• 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