MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV PACIFIC PLUS US; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Catalog Number	PCP060300150
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a post-dilation balloon procedure, which was the final step of treatment for plaque in the mid right superficial femoral artery (peripheral artery disease), a balloon twist/dog-bone twist was visible within the balloon in the vessel using a pacific plus us catheter.The artery diameter was 6 millimeters and the degree of tortuosity was minimal.Embolic protection was used with a spiderfx device.The balloon was inflated with a 50/50 contrast solution using an inflation device.No resistance was encountered when advancing the device.The device was safely removed from the patient.No patient complications have been reported as a result of this event.
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: PACIFIC PLUS US
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo cucapah 10510 el lag; tijuana baja california,mx 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo cucapah 10510 el lag; tijuana baja california,mx 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24108659
• Report Number: 9617601-2026-00351
• Device Sequence Number: 20287622
• Product Code: LIT
• UDI-Device Identifier: 08033477072029
• UDI-Public: (01)08033477072029(17)280129(10)230576939
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K123358
• 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
• Report Date (Section B): 01/19/2026

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: PCP060300150
• Device Lot Number: 230576939
• 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: 01/02/2026
• Initial Report FDA Received Date: 01/19/2026
• Date Device Manufactured: 01/29/2025
• 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