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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 PCF050150130
Device Problem Packaging Problem (3007)
Patient Problem Intimal Dissection (1333)
Event Date 01/18/2017
Event Type  Injury  
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to treat a lesion in the peroneal artery. A 3 mm x 150 mm balloon size was requested. The box was opened prior to use and the pouch labelling was not checked against the carton of the device. The balloon was prepped and inserted as per ifu. During inflation the surgeon realized the balloon appeared bigger than the requested 3 mm balloon. When reviewing the packaging and the inner pouch it was then realized that the device was labelled as a 5 mm x 150 mm. The balloon was removed and another 3 mm x 150 mm was used. A xience stent was required to treat a dissection of the peroneal artery. The surgeon was unsure if this was caused by the 5 mm x 150 mm balloon inflation. Post procedure good run off to distal vessels. Mismatch between box label, and pouch label, device hub/luer. The nurse cannot recall opening the box, therefore cannot confirm if the seals were broken before opening the box prior to use.
 
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, 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 Key6338599
MDR Text Key67649989
Report Number9612164-2017-00183
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeAS
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 01/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2017
Device Catalogue NumberPCF050150130
Device Lot Number208555733
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 Received01/18/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/22/2014
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: 02/17/2017 Patient Sequence Number: 1
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