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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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MEDTRONIC MEXICO PACIFIC XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Catalog Number PCF050200130
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/26/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use a pacific xtreme pta balloon during a procedure to treat a plaque lesion in the patient's mid superficial femoral artery (sfa). No vessel tortuosity or calcification reported. Lesion exhibited 70% stenosis. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray. There were no issues noted when removing the device from the hoop/tray. The device was  prepped per ifu with no issues identified. Balloon was prepared under normal steps and no problem was shown. The device did not pass through a previously deployed stent. No resistance was encountered during advancement. After inflation in lesion, the balloon showed a twist in the middle. A rewrap tool was not used. Physician decided to deflate and take out the balloon. No problem was involved. A replacement balloon was  used to complete the procedure. No patient injury reported.
 
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Brand NamePACIFIC XTREME
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13167437
MDR Text Key289866500
Report Number9612164-2022-00038
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K103464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPCF050200130
Device Lot Number222073742
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2021
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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