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

Catalog Number PCF060200130

Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2019

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 balloon during treatment of a lesion in the patient¿s superficial femoral artery (sfa). Ifu was followed. The device was prepped without issue. An inflation device was used for balloon inflation. It is reported that balloon inflation difficulties were experienced at an inflation pressure of 14atm. The entire balloon did not inflate, and a twist was observed. The balloon was deflated and re-inflated, but the twist remained in the middle. The proximal and distal ends of the balloon are reported to have been at nominal diameter. The procedure was completed with the same pta moving up and down. No patient injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: the balloon was safely removed from the patient. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: the pacific xtreme was received in a post-inflation profile, (e. G. Not tightly wrapped or winged). A visual examination of the catheter revealed witness marks of a balloon twist in the distal 1/3 of the balloon chamber. A 10cc water filled syringe was attached to the proximal hub luer lock and the guidewire lumen was flushed: a steady stream of fluid was observed exiting the distal tip of the catheter. A 0. 018¿ compatible guidewire was able to be loaded with ease through the distal tip of the catheter and navigated out the proximal hub of the catheter with ease. A 10cc water filled syringe was attached to the inflation lumen luer lock of the y-manifold, a vacuum could be pulled and maintained. The balloon chamber was lightly inflated with the water filled syringe and witness marks of a balloon twist were noted. The balloon twist witness marks are approximately 7. 5cm from the distal tip of the balloon catheter. 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; 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: 9278540
• MDR Text Key: 165992942
• Report Number: 9612164-2019-04640
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K103464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/31/2020
• Device Catalogue Number: PCF060200130
• Device Lot Number: 213428839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial