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

Catalog Number	AB35W04150135
Medical Device Problem Codes	Burst Container or Vessel (1074); Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Ia physician was using an evercross pta balloon for treatment of a plaque lesion with 60% stenosis in the distal region of the superficial femoral artery.Embolic protection was not used.The device was prepped as per the ifu with no issues identified.There was no resistance during advancement and the device did not pass through a previously deployed stent.A syringe was used for inflation.It was reported the patient was diagnosed with lower extremity arteriosclerosis and occlusion, and was to undergo arterial balloon dilatation and stent implantation.After angiography, it was confirmed that the patient had superficial femoral artery stenosis.First, the pta balloon dilatation catheter was used for dilatation.The balloon was inflated to the rated standard pressure and the balloon expanded normally.Then the balloon was withdrawn and it was found that balloon dilation was poor.After withdrawal, blood was found in the balloon.It is thought the balloon had ruptured.Another balloon was used to complete the subsequent dilatation.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: one prior inflation was applied.The balloon burst at 9atm and a longitudinal burst was reported.The balloon did not fragment.No damage was noted to the balloon catheter.The use of a pressure pump with negative pressure suction was required for deflation.Deflation took 3 minutes but the balloon did not fully deflate.The balloon was directly removed from the body with no vessel injury noted.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product analysis: the device was returned with the balloon in a post-inflated state.The device was flushed and the balloon was inflated to its nominal pressure of 10atms.The device would not hold pressure and a leak was found at the balloon bond.A visual inspection found damage to the balloon bond at the leak site.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EVERCROSS 035
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19528444
• Report Number: 2183870-2024-00190
• Device Sequence Number: 7681476
• Product Code: LIT
• UDI-Device Identifier: 00763000184032
• UDI-Public: 00763000184032
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2024

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: 11/20/2025
• Device Catalogue Number: AB35W04150135
• Device Lot Number: B480733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 06/18/2024; 09/10/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/11/2024; 09/12/2024
• Date Device Manufactured: 11/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male