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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
Model Number PCU060150130
Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/07/2020
Event Type  malfunction  
Manufacturer Narrative
Image review: three photographic images of cine images were received for evaluation. The images are of the patient¿s distal right superficial femoral artery. A radiopaque ruler is in all three images. In the first image the pta balloon catheter is inflated. A candy wrapper twist/ ¿dog boning¿ is visible in the image at approximately the 24cm mark on the radiopaque ruler. The second image is of the pta balloon catheter inflated but no candy wrapper twist/ ¿dog bone¿ is visible in the image. The third image appears to be a cropped enlargement of the pta balloon catheter inflated with a candy wrapper twist/ ¿dog bone¿ visible in the image at approximately 21cm mark on the radiopaque ruler. Product analysis: two pacific xtreme pta balloon catheters were received loaded within their protective transportation hoops. Neither of the balloons nor the hoops were identified as being the first unit used or second unit used in the procedure. No ancillary devices were received for evaluation. One of the pacific xtreme pta balloon catheters was randomly selected to be the first unit used in the procedure. The balloon catheter was received with the balloon chamber in a post-inflation profile, (e. G. Not tightly wrapped or winged). No obvious balloon chamber material twisting, (candy wrapping or dog boning), witness marks were noted in the visual inspection. A 10cc water filled syringe was attached to the proximal hub luer lock and the guidewire lumen was flushed; sanguine residue and tinted fluid was observed exiting the distal tip of the balloon catheter. A 0. 018¿ compatible guidewire was loaded through the distal tip of the balloon catheter and navigated with ease out the proximal hub luer lock of the y-manifold. The lot number data printed on the y-manifold is consistent with the reported event. A 10cc water filled syringe was used to lightly inflate the balloon chamber. Faint witness marks of a balloon chamber material twist were noted.
 
Event Description
Physician intended to use a pacific xtreme pta balloon to post-dilate a non-medtronic stent during treatment of a 300mm cto (chronic total occlusion-100%) in the patient¿s distal right superficial femoral artery (sfa) of diameter 6mm. Moderate vessel tortuosity and calcification are reported. No damage noted to packaging prior to use. No issues noted when removing the device from the packaging. Ifu was followed and negative prep was performed without issue. Pre-dilation was not performed. The device was passed through the deployed stent without encountering resistance post atherectomy. It is reported that during attempted inflation, dog-boning was observed at an inflation pressure of 3atm. The device was replaced with another pacific xtreme device, but the same issue was experienced at an inflation pressure of 6atm. There was no twist or kink noted on the balloons when removed from the patient. Both devices were safely removed from the patient. No vessel damage occurred. A non-medtronic balloon was used to complete the procedure. A non-medtronic stent was placed. No patient injury reported.
 
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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 Key10086266
MDR Text Key192025959
Report Number9612164-2020-01974
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103464
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 05/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCU060150130
Device Catalogue NumberPCU060150130
Device Lot Number219105117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2019
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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