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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 PCF050200130
Device Problem Defective Device
Event Date 01/19/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that balloon inflation difficulties occurred during procedure. The balloon could not be opened completely. No patient injury reported.

 
Manufacturer Narrative

Device evaluation: visual and tactile inspections were performed. The device was blood-stained. The purging phase was performed, but revealed a leak. A longitudinal cut was found on the distal portion (6cm) of the balloon starting from the distal balloon welding. It was possible to insert the 0,018¿¿ guide wire without any resistance. No further issues found.

 
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 Key6408769
Report Number9612164-2017-00279
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/31/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/16/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPCF050200130
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/28/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2017
Was Device Evaluated By Manufacturer? Yes
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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