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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
Catalog Number PCU070200130
Device Problem Burst Container or Vessel (1074)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/27/2017
Event Type  Injury  
Event Description
Physician employed the use of a pacific xtreme pta balloon catheter with a non-mdt inflation device for the treatment of a 100% stenosed fibrous/plaque lesion in the mid-proximal superficial femoral artery (sfa). Lesion was slightly calcified. Vessel slightly tortuous. Ifu was followed. Device prepped without issue. It was reported that a circumferential/radial balloon burst occurred at an inflation pressure of 8-9atms. One inflation was applied to the balloon previous to burst. The device did pass through a previously deployed stent, but no resistance was encountered / no excessive force required. A part of the balloon ruptured off the catheter and became lodged within the mid-sfa. A 10mm snare device was used to retrieve the ruptured balloon (all fragments retrieved). No patient injury was reported.
 
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Brand NamePACIFIC XTREME
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer (Section G)
MEDTRONIC MEXICO
avenida paseo del cucapah #105
parque industrial el lago
tijuana,bc 22570
MX 22570
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7127035
MDR Text Key95175252
Report Number9612164-2017-01998
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
Report Date 12/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue NumberPCU070200130
Device Lot Number213333749
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 Received11/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/18/2017 Patient Sequence Number: 1
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