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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
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.
 
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Brand NamePACIFIC XTREME
Type of DeviceCATHETER, 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 Key9278540
MDR Text Key165992942
Report Number9612164-2019-04640
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K103464
Number of Events Reported1
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 Received11/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2020
Device Catalogue NumberPCF060200130
Device Lot Number213428839
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/05/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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