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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 PCF050250090
Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2022
Event Type  malfunction  
Event Description
Physician was attempting to use the pacific xtreme balloon during procedure to treat moderately calcified plaque in the mid superficial femoral artery. The vessel had moderate tortuosity and exhibited cto (chronic total occlusion-100%). The balloon was inflated with a syringe. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray. The device was prepped per the ifu with no issues. The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device. It was reported that there were balloon inflation difficulties during inflation. A balloon twist occurred and rewrap issue was noted. A rewrap tool was not used. The ¿twist¿ was noted at around 6 atm and the balloon was deflated in the usual way and reinflated after repositioning more distally to exclude the possibility of a focal stenos is that prevented the balloon from deploying totally. The problem occurred again with the twist seem at the same site in the balloon and a different site with respect to the artery. No specific measures were taken to deflate the balloon and deflation time was within the normal range. The device was safely removed from the patient with no complications encountered. The procedure was completed by deploying the device and using another non-medtronic product. No patient injury.
 
Manufacturer Narrative
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, 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 Key13900228
MDR Text Key289457380
Report Number9612164-2022-01170
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSZ
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 07/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPCF050250090
Device Lot Number222073744
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2022
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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