MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT 018 PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOO; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number IPU07008013P

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2024

Event Type  malfunction  

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 Description

A physician was attempting to use an inpact 018 drug coated balloon with a 6fr non-medtronic sheath and a 235cm 0.014 non-medtronic guidewire during procedure to treat a 60mm plaque lesion in the patients left proximal superficial femoral artery.No vessel tortuosity and moderate vessel calcification were reported.Lesion exhibited cto (chronic total occlusion-100%) stenosis.Artery diameter is reported as 7mm.There were no anatomical abnormalities reported.There were no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu (instruction for use) with no issues noted.Embolic protection was not used.A non-medtronic inflation device was used for balloon inflation.A balloon twist was reported.It was not possible to apply drug to one area due to the twisting of the balloon.A rewrap tool was not used.The device did not pass through a previously deployed stent.No resistance was encountered when advancing device.An additional inpact 018 was used to complete procedure.No patient injury reported.

Manufacturer Narrative

Additional information: inflation fluid was used.A noted dog-bone/twist was visible within the balloon in the vessel.Even if the pressure was increased to the recommended pressure (8atm), the twisting did not release, and even though the pressure applied to rbp, it could not be released.The device was safely removed from the patient.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 018 PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOO
• Type of Device: 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: 19200462
• MDR Text Key: 341247859
• Report Number: 9612164-2024-02030
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: IPU07008013P
• Device Lot Number: 0012070419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/04/2024
• Supplement Dates FDA Received: 05/27/2024
• Date Device Manufactured: 12/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1