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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 PCF050300130
Device Problem Defective Device
Event Date 07/21/2016
Event Type  Malfunction  
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

During an attempt to treat a lesion using pacific xtreme, it was reported that balloon twist occurred during use. No patient injury or clinical sequelae reported for this event.

 
Manufacturer Narrative

Results: operational problem - 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 evaluation codes: conclusion: operational context caused or contributed to event - 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 device evaluation: a visual and tactile inspections were performed. A bubble in the luer bonding was detected and highlighted through a microscope. However it does not affect the device performance. No damages has been noted on the shaft. The balloon was used. A wrinkled area was noted on the balloon at approximately 15 cm form the proximal 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 4 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.

 
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 Key5885938
Report Number9612164-2016-00865
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/12/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/18/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2019
Device Catalogue NumberPCF050300130
Device LOT Number210671568
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/09/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/19/2016
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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