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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 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.
 
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Brand NamePACIFIC XTREME
Type of DeviceCATHETER, 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 Key9919579
MDR Text Key192151961
Report Number9612164-2020-01463
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCS
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
Report Date 04/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/26/2021
Device Catalogue NumberPCF050150130
Device Lot Number216673799
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/26/2018
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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