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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 PCU050300130
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2020
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 during procedure. There was no damage to device packaging. There was no issues noted when removing device from hoop/tray. The device was inspected with no issues noted. Balloon inflation difficulty occurred. It was reported that during balloon inflation, balloon wrap occurred and the balloon did not inflate in center. The vessel was not pre dilated. The device did not pass through previously deployed stent. There was no resistance encountered when advancing device. There was no patient injury reported.
 
Manufacturer Narrative
Additional information: a dog -bone/ twist was visible within the balloon in the vessel. A re wrap tool was not used. The procedure was completed using a new balloon. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: event date provided. 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 Key10107875
MDR Text Key193366663
Report Number9612164-2020-02039
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,Followup,Followup
Report Date 09/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCU050300130
Device Catalogue NumberPCU050300130
Device Lot Number219018139
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 Received09/23/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/26/2019
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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