MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC PLUS US; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Catalog Number	PCP030120150
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
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 co2 angiogram of the right leg, diffuse disease was observed throughout the entire right anterior tibial artery.The lesion length was 250mm and the target lesion was plaque.Lesion stenosis was 60-70%.There was minimal tortuosity and calcification.The artery was 3mm in diameter.  a pacific plus balloon was used for a three-segment percutaneous transluminal angioplasty (distal, middle, proximal).After the initial procedure, a follow-up co2 angiogram showed minimally improved flow, prompting a repeat of the angioplasty.During the procedure, difficulty was encountered when attempting to back out the balloon over the wire, as it kept getting caught.The balloon was fully deflated, the balloon catheter was flushed, and the wire was wet.The wire was changed but despite using a new wire, the issue persisted.Pta was then done on the proximal segment of the right anterior tibial artery.When that was done, and the balloon was fully deflated, the physician then attempted to remove the balloon over the wire again, and even with great force was unable to back the balloon out.The physician ultimately removed both the wire and the balloon together, risking loss of access to the target vessel.With both the balloon and the wire outside of the patient, the scrub tech tried to remove the wire from the balloon catheter and was successful after pulling with great force on the wire.Examination of the balloon and wire showed no kinks or obstructions or possible ledges that the wire could have gotten caught on.Scrub tech then flushed the balloon catheter, and didn't feel any blockage or obstruction in the balloon catheter while flushing.The procedure continued, and the lesions found in different below-the-knee arteries were treated with a non medtronic balloon as well as the wire used with the pacific plus, no patient injury.
Additional Manufacturer Narrative
Product analysis: the device was returned with the balloon in a post-inflated state.A 20ml water filled syringe was used to flush the device and a steady stream of water was observed exiting the tip.A 0.014¿ guidewire was loaded through the tip and exited through the luer without issue and could move freely.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; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21322240
• Report Number: 9612164-2025-00641
• Device Sequence Number: 18316926
• Product Code: LIT
• UDI-Device Identifier: 08033477071701
• UDI-Public: 08033477071701
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Followup
• Report Date (Section B): 03/31/2025

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: PCP030120150
• Device Lot Number: 228788324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/31/2025
• Date Device Manufactured: 04/30/2024
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 106 KG