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

Catalog Number	AB35W08060135
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
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
Physician attempted to use an evercross 035 pta balloon with a 6fr sheath and a.014 guidewire during treatment of a 60mm fibrous lesion in the patients right mid common iliac artery.No vessel tortuosity and minimal vessel calcification were reported.Artery diameter reported as 7.5mm.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.The device was prepped per the ifu (instruction for use) with no issues identified.Embolic protection was not used.An inflation device was used for balloon inflation.Contrast inflation fluid was used.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device.A circumferential/radial balloon burst occurred on first inflation at 8atms.The balloon broken horizontally and half of the balloon was in the patient's body.Difficulty removing balloon following balloon inflation was also reported.Physician made a cut on skin for retrieval of the detached component using a snare.A replacement non-medtronic balloon was used to complete the procedure.No patient symptoms or complications reported.
Additional Manufacturer Narrative
Product analysis #: (b)(4): the customer returned one image for evaluation.The image depicts what appears to be an evercross balloon which has a radial burst.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
Image analysis: the customer returned one image for evaluation.The image depicts what appears to be an evercross balloon which has a radial burst.However, it is not possible to ascertain from the returned image at what point during the procedure he burst occurred.Product analysis: a visual inspection of the device confirmed that the balloon burst and approximately 22mm of it detached and that both markerbands are present.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: 19655429
• Report Number: 2183870-2024-00202
• Device Sequence Number: 6596037
• Product Code: LIT
• UDI-Device Identifier: 00763000184834
• UDI-Public: 00763000184834
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 12/02/2024

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: 03/22/2026
• Device Catalogue Number: AB35W08060135
• Device Lot Number: B537146
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 11/25/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/17/2024; 12/02/2024
• Date Device Manufactured: 03/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male