MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	PCU050200130
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: the device was safely removed from the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to use a pacific xtreme pta balloon during procedure to treat a plaque lesion in the mid superficial femoral artery (sfa).There was little degree of tortuosity and little degree of calcification.There was no damage noted to the packaging and no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu and no issues identified.There was no resistance encountered when advancing the device and no excessive force was used.The device was not passed through a previously deployed stent.It was reported that a pinhole balloon leak occurred during balloon inflation at nominal pressure.No balloon fragments remained in the patient.There was no injury to the patient.The procedure was completed using a new balloon.

• Brand Name: PACIFIC XTREME
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9591344
• Report Number: 9612164-2020-00247
• Device Sequence Number: 3244580
• Product Code: LIT
• UDI-Device Identifier: 08033477058467
• UDI-Public: 08033477058467
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2020

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: 08/01/2021
• Device Model Number: PCU050200130
• Device Catalogue Number: PCU050200130
• Device Lot Number: 215949680
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/15/2020; 04/17/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 01/17/2020; 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1