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

Model Number PCP025080150

Device Problems Inflation Problem (1310); Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2020

Event Type  malfunction  

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 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
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 10682286
• MDR Text Key: 219345100
• Report Number: 9612164-2020-03923
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial