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

Catalog Number PCF050150130

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a pacific xtreme during treatment of the patient¿s popliteal artery.No damage noted to packaging prior to use.No issues noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.The device was not passed through a previously deployed stent and no resistance was noted during advancement.It is reported balloon inflation difficulties were noted and nominal pressure could not be reached.A balloon leak was reported.The device was safely removed from the patient and was replaced to complete the procedure.No patient injury reported.

Manufacturer Narrative

Device evaluation: the pacific xtreme pta balloon catheter was received with the balloon chamber in a post-inflation profile, (e.G.Not tightly wrapped or winged), with sanguine residue within the balloon chamber.A 10cc water filled syringe was attached to the proximal hub luer lock of the y-manifold and the guidewire lumen was flushed; a clear steady stream of fluid was observed exiting the distal tip of the catheter.A 0.018¿ guidewire was able to be loaded with ease through the distal tip and navigated out the proximal hub luer lock.A 10cc water filled syringe was attached to the inflation lumen luer lock and a vacuum could be pulled.The balloon chamber was lightly inflated with the water filled syringe a small pinhole leak was noted approximately in the middle of the balloon length.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACIFIC XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9919579
• MDR Text Key: 192151961
• Report Number: 9612164-2020-01463
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Catalogue Number: PCF050150130
• Device Lot Number: 216673799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 04/29/2020
• Date Device Manufactured: 11/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR