MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT AV ACCESS; DRUG-COATED PERIPHERAL TRANSLUMINAL ANGIOPLAST

Catalog Number	IAV05008008P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
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
Physician was attempting to use in.Pact av ballon to treat patient's cephalic vein.A 6fr non-medtronic sheath and 0.035 non-medtronic guidewire was used.The device was prepped per ifu and syringe was used to inflate the balloon.It was reported during first infaltion a balloon burst occurred and extended at nominal pressure of 8 atmosphere.Resistance occured during delivery.The balloon was removed.No patient injury reported.Bur.
Additional Manufacturer Narrative
Additional information: the balloon did not fragment, no foreign objects remain in the blood vessel and the device was safely removed from the patient.No, i ntervention was performed/required to remove the balloon.As the lesion was dilated, the procedure was completed without additional intervention.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 visual inspection: the size on luer consistent with gch the balloon cover was partially loaded on the balloon the balloon was in the post inflation state the device was connected to an inhouse in deflator the balloon inflated to 14atm with no issues 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.

• Brand Name: IN.PACT AV ACCESS
• Common Device Name: DRUG-COATED PERIPHERAL TRANSLUMINAL ANGIOPLAST
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22952354
• Report Number: 9612164-2025-04348
• Device Sequence Number: 9636638
• Product Code: PRC
• UDI-Device Identifier: 00763000232535
• UDI-Public: (01)00763000232535(17)280506(10)0012799746
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190008
• 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): 12/01/2025

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 Catalogue Number: IAV05008008P
• Device Lot Number: 0012799746
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 11/26/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/11/2025; 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown