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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 PCF050250130
Device Problem Defective Device
Event Date 10/17/2016
Event Type  Malfunction  
Manufacturer Narrative

Results: the root cause is related to the direction of the folding pleats which appear not to be folded parallel to the shaft of the device. Once inside the artery, the folding pleats most likely encounter resistance related to a tight lesion, resulting an incomplete balloon expansion. Conclusion: the root cause is related to the direction of the folding pleats which appear not to be folded parallel to the shaft of the device. Once inside the artery, the folding pleats most likely encounter resistance related to a tight lesion, resulting an incomplete balloon expansion. (b)(4). Device evaluation: a visual and tactile inspections were performed. No damages has been noted on the shaft. The balloon was used. A wrinkled area was noted on the balloon at 15 cm form the proximal balloon welding. The guide wire lumen was flushed and it was possible to insert the 0,018 guide wire without any resistance. The purging procedure was performed with no issues. The balloon was inflated at 1 bar and its profile resulted deformed in the point of twisting. The deformation disappeared increasing the inflating pressure over 5 bar. It was possible to note a deformation point on the guide wire tube just below the wrinkled area, identified as point of twist. No further issues found.

 
Event Description

During an attempt to treat a lesion in the sfa using pacific xtreme dilatation balloon catheter, it was reported that balloon twist occurred during inflation. The balloon had a twist in the middle which created issues when inflating the balloon. No patient injury reported.

 
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 Key6102925
Report Number3004066202-2016-00283
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/17/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/15/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2017
Device Catalogue NumberPCF050250130
Device LOT Number208345675
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/08/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/13/2014
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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