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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 PCU060200130
Device Problem Defective Device
Event Date 05/12/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

A physician was attempting to use a pacific xtreme to treat a moderately calcified, moderately tortuous fibrous lesion in the sfa with 90% stenosis. It was reported that during balloon inflation, balloon the center of the balloon would not inflate, a balloon twist occurred, the balloon would not unwrap. The twist occurred during inflation at 12 atm. The device passed through a previously deployed stent. The procedure was completed using another balloon. There was no injury to patient.

 
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 Key6639448
Report Number9612164-2017-00754
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/16/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/14/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2019
Device Catalogue NumberPCU060200130
Device LOT Number211401920
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 Received05/16/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/09/2016
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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