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U.S. Department of Health and Human Services

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

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MEDTRONIC MEXICO PACIFIC PLUS CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number PCE050120130
Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2019
Event Type  malfunction  
Manufacturer Narrative
Additional information: the balloon did not fragment. The procedure was completed using another pacific plus balloon of same size and a drug coated balloon in the target lesion. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Device evaluation the pacific plus balloon catheter was received with the balloon chamber in a post-inflation profile, (e. G. Not tightly wrapped or winged). Sanguine residue was observed within the balloon chamber; indicating communication between the balloon chamber and a sanguine environment, (e. G. Leak). A 10cc water filled syringe was attached to the proximal hub luer lock and the guidewire lumen was flushed; sanguine coloured fluid was observed exiting the distal tip of the catheter. The guidewire lumen was flushed until the fluid exiting the distal tip was clear. A 0. 018¿ guidewire was loaded through the distal tip with ease and navigated out the proximal hub with ease. A 10cc water filled syringe was attached to the inflation lumen luer lock of the y-manifold and a vacuum was pulled but could not be maintained; indicating a leak in either the inflation lumen or balloon chamber. The water filled syringe was lightly pressurized to inflate the balloon chamber. A pinhole leak was located in the proximal end of the balloon chamber. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a pacific plus balloon catheter to treat a non calcified soft tissue lesion in the sfa. The device was prepped per ifu with no issues identified. It was reported that during balloon inflation, a pin hole burst occurred at 4atm at first inflation. All fragments of the balloon was retrieved. The device did not pass through a previously-deployed stent and no resistance encountered when advancing the device. Physician used another medtronic balloon of same size to complete procedure. There was no patient injury reported, contrast leakage inside patient was noted by physician while trying to do the first inflation.
 
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Brand NamePACIFIC PLUS
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 Key9334710
MDR Text Key182830759
Report Number9612164-2019-04780
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K123358
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
Report Date 02/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/15/2021
Device Catalogue NumberPCE050120130
Device Lot Number216617695
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2018
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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