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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Catalog Number PCF050150130
Device Problems Leak/Splash (1354); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2021
Event Type  malfunction  
Manufacturer Narrative
Product analysis: the pacific xtreme pta balloon was returned to medtronic investigation lab for evaluation. The device was returned coiled in its pouch inside a biohazard bag. A visual inspection found the balloon in a pre-inflated state. A 20ml water filled syringe was used to flush the device and a steady stream of water was observed exiting the tip. However, the balloon began to inflate during the flushing indicating a leak between the inner lumen and inflation lumen. The strain relief was removed, and bunching/ damage was visible on the shaft. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use the pacific xtreme pta balloon to treat moderately calcified plaque in the left superficial femoral artery(sfa). The vessel exhibited 85% stenosis and had moderate tortuosity. No embolic protection was used. There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray. Device was prepped per ifu with no issues. It was reported that there was failure to cross/position. There was severe resistance felt during advancement. No excessive force was used. After the puncture was successful, the 18'' guidewire was inserted and the pacific xtreme pta was selected. The guidewire could not pass through the balloon. The balloon was replaced with same model balloon. The device was safely removed. There was no vessel damage. The guidewire passed through and was positioned at the lesion to expand for 3 minutes then exited the balloon angiography. The blood flow in the original stenosis was smooth and operation finished. No patient injury reported.
 
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Brand NamePACIFIC XTREME
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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 
EI  
091708734
MDR Report Key12793538
MDR Text Key285000122
Report Number9612164-2021-04338
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K103464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPCF050150130
Device Lot Number220855908
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2021
Date Manufacturer Received11/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/28/2020
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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