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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER

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ABBOTT VASCULAR ARMADA 35 PTA CATHETER Back to Search Results
Model Number REF B1120-060
Device Problems Wire (430); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/24/2014
Event Type  Malfunction  
Event Description

Prior to inserting in pt, staff unable to advance wire in catheter, never reached pt.

 
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Brand NameARMADA 35
Type of DevicePTA CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
santa clara CA 95054
MDR Report Key4398671
MDR Text Key5301727
Report NumberMW5040053
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/31/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/31/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2017
Device MODEL NumberREF B1120-060
Device LOT Number31023G1
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

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