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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 Deflation Problem (1149); Inflation Problem (1310); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a pacific xtreme pta balloon catheter along with a non-medtronic 6fr sheath and a 0. 014 guide catheter during procedure to treat a little calcified plaque lesion in the mid superficial femoral artery (sfa). The vessel diameter and lesion length are 6mm and 270mm respectively. There was no damage to product packaging. There was no issues noted when removing device from hoop/tray. The device was inspected per ifu with no issued identified. During balloon inflation, inflation difficulty was observed at 4atm. During balloon inflation, the balloon was slow to deflate, with 40 sec for balloon to deflate. Balloon twist occurred with rewrap issue noted. It was reported that physician continues to have problems with the 5 mm and 6 mm 300mm balloons twisting upon inflation and are extremely slow to deflate whenever this twisting occurs. Another medtronic balloon was used to complete the procedure. There was 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 Key10183991
MDR Text Key196090106
Report Number9612164-2020-02295
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 07/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCU060300130
Device Catalogue NumberPCU060300130
Device Lot Number218454476
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 Received06/23/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/11/2019
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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