MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	ADM06008013P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
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
It was reported that during a peripheral artery disease procedure to treat a calcified lesion in the left mid superficial femoral artery, the inpact admiral drug coated balloon 018 burst during the procedure.The common femoral artery was described as highly calcified, and vessel preparation was performed using a 7mm non-medtronic device.A non-medtronic inflation device was used with 50/50 contrast fluid for inflation.After the first drug coated balloon burst on initial inflation, a second inpact admiral drug coated balloon was used, which also burst.The devices were safely removed from the patient.The procedure was completed after the second balloon burst.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional infomration: the balloon burst below rbp.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
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
It was reported that during a peripheral artery disease procedure to treat a calcified lesion in the left mid superficial femoral artery, the in-pact admiral drug coated balloon 018 burst during the procedure.The common femoral artery was described as highly calcified, and vessel preparation was performed using a 7mm non-medtronic device.A non-medtronic inflation device was used with 50/50 contrast fluid for inflation.After the first drug coated balloon burst on initial inflation, a second in-pact admiral drug coated balloon was used, which also burst.The devices were safely removed from the patient.The procedure was completed after the second balloon burst.No patient complications have been reported as a result of this event.Additional infomration: the second balloon burst also occurred on the first inflation at, below, or at an unknown rated burst pressure, leading to the procedure being aborted.A 6x45 non-medtronic sheath and 014x300 non-medtronic guidewire were used.
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.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• 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: 22267837
• Report Number: 9612164-2025-02989
• Device Sequence Number: 7198008
• Product Code: ONU
• UDI-Device Identifier: 00643169383272
• UDI-Public: (01)00643169383272(17)271119(10)0012548639
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/29/2025

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 Model Number: ADM06008013P
• Device Catalogue Number: ADM06008013P
• Device Lot Number: 0012548639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 07/17/2025; 08/25/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/24/2025; 07/24/2025; 08/29/2025
• Date Device Manufactured: 11/19/2024
• 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