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

Catalog Number	PCP020040150
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to use a pacific plus pta balloon with a 6x45 non-medtronic (terumo destination) sheath and a.018 non-medtronic (abbott command) guidewire during treatment of an 80mm calcified lesion in the patient¿s left distal anterior tibial artery.Moderate vessel tortuosity and severe vessel calcification were reported.Lesion exhibited 70% stenosis.Artery diameter reported as 2.5mm.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.No issues were noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure without issue.Embolic protection was not used.The vessel was not pre or post dilated.A non-medtronic (boston scientific encore) inflation device was used for balloon inflation.50/50 contrast fluid was used.The balloon was not passed through a previously deployed stent.Severe resistance was noted during advancement of the device.Inflation difficulties were reported.The balloon wouldn¿t maintain pressure.No leaks were noted on the device.The device was safely removed from the patient and the procedure was aborted.No patient injury reported.When the device was returned for evaluation, it was noted that there was a pinhole leak in the balloon.
Additional Manufacturer Narrative
Product analysis a 20ml water filled syringe was used to flush the device and a steady stream of water was observed exiting the tip.A 0.018¿ guidewire from the lab was loaded through the tip and exited through the luer, an indeflator was used to inflate the balloon but the device would not hold pressure and a pinhole leak was found 0n the distal end of the balloon, 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: 19349938
• Report Number: 9612164-2024-02396
• Device Sequence Number: 7148178
• Product Code: LIT
• UDI-Device Identifier: 08033477071596
• UDI-Public: 08033477071596
• 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
• Report Date (Section B): 05/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2025
• Device Catalogue Number: PCP020040150
• Device Lot Number: 224424709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 64 KG