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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 PCF050200090
Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528)
Patient Problems Thrombus (2101); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Event Date 02/08/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician was attempting to use a pacific xtreme balloon to treat multiple moderately calcified left sfa lesions (stenosis 95%). The artery was 6mm in diameter and non-tortuous. The device was removed from its packaging and inspected with no issues noted. The device was prepped as per the ifu. The procedure used a non-medtronic guidewire, 5 fr sheath and no embolic protection was used. The lesion was not pre-dilated. There was no resistance advancing the device and no excessive force was used. The device did not pass through a previously deployed stent. The device was first used for one inflation in the popliteal lesion with no issues. During inflation in the sfa at 10 atm, a circumferential balloon burst occurred. The physician recaptured the balloon and positioned a non-medtronic stent to jail the remaining balloon piece to the vessel wall. The doctor reported that the procedure to recapture the balloon and to position a stent was difficult and required a long time. It was reported that the piece detached from the pacific xtreme pta balloon was inside the vessel for a long time causing thrombus formation in the vessel. It is further reported that the thrombus embolised. It was not possible to administer an adequate heparin dose for the patient age and general condition. The leg of the patient was severely compromised before the intervention (signs of ulcers) and the situation seemed to be worse the end, probably caused by distal embolization.
 
Manufacturer Narrative
Evaluation summary: the device was not returned for evaluation. An image was provided showing the device in vitro after the procedure. The balloon was broken and a part of it was not present. The image confirmed the event reported from the field (burst with balloon detachment). A cd with angio images was provided. The cd showed the procedure: guidewire tracking through the lesion, balloon insertion, balloon inflation, vessel flow observation after the burst (loss of vascularization), multiple attempts to insert another guidewire into the vessel obstructed by the balloon, stent application and multiple stent post dilatation. Moreover vessel bleeding occurred distally to the stent and further balloon inflation was performed and successfully compressed the vessel. 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
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 Key7323795
MDR Text Key101886992
Report Number9612164-2018-00480
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K103464
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/21/2020
Device Catalogue NumberPCF050200090
Device Lot Number214065379
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 Received05/09/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/21/2017
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: 03/08/2018 Patient Sequence Number: 1
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