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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 PCU060300130
Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/11/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician used a pacific xtreme pta balloon with a non-medtronic 6fr sheath and 0. 014 guidewire during treatment of a >250mm plaque lesion in the patient¿s mid right superficial femoral artery (sfa) of diameter 6mm. Moderate vessel calcification is reported. 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. It is reported balloon inflation difficulties were noted. The balloon appeared to be stuck to the catheter. A balloon twist is reported. Procedure was completed with same balloon. The physician advanced to and inflated where it was sticking to catheter. No vessel damage was noted. The device was safely removed from the patient. No patient injury reported.
 
Manufacturer Narrative
Image review: two photographic images were received for evaluation. The first image is of a procedural cine image of the patient¿s mid right superficial femoral artery based on anatomical landmarks. In the cine image the pta balloon catheter is inflated and three balloon twists ¿candy wrapping¿ are visible. The second image the pta balloon catheter has been removed from the patient and is inflated. In this photograph at the proximal end of the balloon chamber there are only two balloon twists ¿candy wrapping¿. It is noted that the inner guidewire lumen is undulating within the balloon chamber an indication that the balloon may have been over inflated. 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
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 Key9881971
MDR Text Key190341983
Report Number9612164-2020-01352
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,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCU060300130
Device Catalogue NumberPCU060300130
Device Lot Number218712741
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/16/2019
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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