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

Catalog Number IPU07008013P

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/22/2024

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 using an in.Pact 018 drug coated balloon (dcb) for treatment of a 70mm plaque lesion  in the proximal region of the  superficial femoral artery.There was moderate calcification and no tortuosity.A 6fr non medtronic sheath and a non medtronic guidewire was used.Embolic protection was not used.A non medtronic device was used for inflation with saline mixed solution.There were no issues noted when removing from packaging and the device was prepped as per the ifu with no issues identified.The device did not pass through a previously deployed stent.No resistance occurred during delivery.It was reported during inflation of the device at 8atm balloon twisting occurred and the balloon could not expand at the center.Problems occurred with refill.No patient injury was reported.

Manufacturer Narrative

Product analysis the device returned with the balloon folds expanded.No deformation was evident to the catheter body.A kink was evident to the proximal balloon working length, a twist was evident to the mid-section of the balloon working length.The balloon was inflated with no issues, a twist was observed on the balloon and inner member.No deformation to the distal tip.No other deformation to the remainder of the device.Image analysis one still image was received from the account for review.The image shows a screenshot of a fluoroscopy still of the procedure.The image show the balloon in the patients vascular with ¿dog-boning¿ evident, typical of a balloon twist.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 ANGIOPLAS
• 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: 19071562
• MDR Text Key: 339802016
• Report Number: 9612164-2024-01681
• 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
• Report Date: 04/09/2024

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: 0011969965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/09/2024
• Date Device Manufactured: 09/27/2023
• 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