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 Codes	Deflation Problem (1149); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was difficulty inserting the catheter and the pacific plus was slow to deflate.The sheath used was a 6fr non medtronic device, and the vessel was pre-dilated with a medtronic pacific plus device.The instructions for use were followed without issue.The device was safely removed, and a new device was used to complete the procedure.No damage was noted to the balloon catheter.The balloon was inflated using a inflations device and no issues were noted during inflation.Contrast/saline inflation fluid was used (% unknown).The balloon was eventually fully deflated for removal normally, the issue was the balloon was not able to be re-inserted for a 2nd time.No patient injury.
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: 23606383
• Report Number: 9617601-2025-02887
• Device Sequence Number: 21311811
• Product Code: LIT
• UDI-Device Identifier: 08033477072029
• UDI-Public: (01)08033477072029(17)280129(10)230576939
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: PCP060300150
• Device Lot Number: 230576939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/20/2025
• 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