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

Model Number	PCP025080150
Medical Device Problem Codes	Inflation Problem (1310); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the pacific plus pta catheter was received within a sealed tyvek pouch, within a nested series of sealed plastic biohazard pouches, and loosely coiled within its opened labeled shelf carton.The lot number data printed on the y-manifold is consistent with the shelf carton label and reported event.No ancillary devices nor procedural images were received for evaluation.The pacific plus catheter was received with the balloon chamber in a post-inflation profile, (e.G.Not tightly wrapped or winged).A 10cc water filled syringe was attached to the proximal hub luer lock of the y-manifold and the guidewire lumen was flushed.Clear fluid was observed exiting the distal tip and the inflation lumen luer lock of the y-manifold.A red food coloring dyed water-filled 3-cc syringe was attached to the inflation lumen luer lock of the y-manifold and pressurized.No communication between the inflation lumen pathway and guidewire lumen was noted within the y-manifold.The syringe was lightly pressurized to fill the inflation lumen and balloon chamber with red dyed fluid.The guidewire lumen distal tip was sealed and packed with putty to create a fluid plug of the distal tip.A 3-cc air filled syringe was attached to the guidewire lumen luer lock of the y-manifold and pressurized; air bubbles were observed were observed entering the balloon chamber in the area of the proximal balloon chamber cone.The leak between the guidewire lumen and inflation lumen was at the proximal balloon chamber cone.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a pacific plus pta balloon with a non-medtronic 0.018 guidewire during treatment of a plaque lesion in th e patient¿s proximal posterior tibial artery.Slight vessel tortuosity and calcification are reported.Lesion exhibited 80% stenosis.No damage was noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue it is reported wire movement issues occurred.The physician reports difficulty when trying to load or exchange the guidewire due to resistance.The wire was eventually able to be passed through the balloon.The device was not passed through a previously deployed stent.Balloon inflation difficulties are also reported.It is reported after passing the wire through the balloon was unable to be inflated.There was no difficulty removing the balloon from the patient and no intervention was required.The balloon was replaced to complete the procedure.No patient injury reported.

• Brand Name: PACIFIC PLUS US
• 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: 10682286
• Report Number: 9612164-2020-03923
• Device Sequence Number: 3161699
• Product Code: LIT
• UDI-Device Identifier: 08033477071657
• UDI-Public: 08033477071657
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K123358
• 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
• Report Date (Section B): 10/15/2020

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: 01/12/2021
• Device Model Number: PCP025080150
• Device Catalogue Number: PCP025080150
• Device Lot Number: 214716101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1