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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO PACIFIC PLUS US CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number PCP025080150
Device Problems Inflation Problem (1310); Device Difficult to Setup or Prepare (1487)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/15/2020
Event Type  malfunction  
Manufacturer Narrative
Product analysis: the pacific plus pta catheter was received within a sealed tyvek pouch, within a nested series of sealed plastic biohazard pouches, and loosely coiled within its opened labeled shelf carton. The lot number data printed on the y-manifold is consistent with the shelf carton label and reported event. No ancillary devices nor procedural images were received for evaluation. The pacific plus catheter was received with the balloon chamber in a post-inflation profile, (e. G. Not tightly wrapped or winged). A 10cc water filled syringe was attached to the proximal hub luer lock of the y-manifold and the guidewire lumen was flushed. Clear fluid was observed exiting the distal tip and the inflation lumen luer lock of the y-manifold. A red food coloring dyed water-filled 3-cc syringe was attached to the inflation lumen luer lock of the y-manifold and pressurized. No communication between the inflation lumen pathway and guidewire lumen was noted within the y-manifold. The syringe was lightly pressurized to fill the inflation lumen and balloon chamber with red dyed fluid. The guidewire lumen distal tip was sealed and packed with putty to create a fluid plug of the distal tip. A 3-cc air filled syringe was attached to the guidewire lumen luer lock of the y-manifold and pressurized; air bubbles were observed were observed entering the balloon chamber in the area of the proximal balloon chamber cone. The leak between the guidewire lumen and inflation lumen was at the proximal balloon chamber cone. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use a pacific plus pta balloon with a non-medtronic 0. 018 guidewire during treatment of a plaque lesion in th e patient¿s proximal posterior tibial artery. Slight vessel tortuosity and calcification are reported. Lesion exhibited 80% stenosis. No damage was noted to the product packaging prior to use. No issues were noted when removing the device from the packaging. Ifu was followed and the device was prepped without issue it is reported wire movement issues occurred. The physician reports difficulty when trying to load or exchange the guidewire due to resistance. The wire was eventually able to be passed through the balloon. The device was not passed through a previously deployed stent. Balloon inflation difficulties are also reported. It is reported after passing the wire through the balloon was unable to be inflated. There was no difficulty removing the balloon from the patient and no intervention was required. The balloon was replaced to complete the procedure. No patient injury reported.
 
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Brand NamePACIFIC PLUS US
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 Key10682286
MDR Text Key219345100
Report Number9612164-2020-03923
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/12/2021
Device Model NumberPCP025080150
Device Catalogue NumberPCP025080150
Device Lot Number214716101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2018
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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