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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number A2015-120
Device Problems Difficult to Remove ; Physical Resistance
Event Date 07/17/2015
Event Type  Malfunction  
Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant products: guide wire: cruise, farbid. Guide catheter: distine 6f 45cm. The customer reported the device was discarded. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.

 
Event Description

It was reported that the procedure was to treat a mildly tortuous, heavily calcified and 99% restenosed anterior tibial artery. An armada 14 balloon catheter was advanced to the lesion with some resistance with the anatomy. The balloon ruptured during the first inflation at 8 atmospheres. There was resistance with the anatomy when removing the balloon catheter. A non-abbott balloon catheter was successfully used to complete the procedure. There was no clinically significant delay in procedure and no adverse patient effects. No additional information was provided.

 
Manufacturer Narrative

(b)(4). It is indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device could not be completed. Based on the reported information, there is no indication of a product quality issue with respect to manufacture, design, or labeling. The investigation determined that the reported resistance and balloon rupture appears to be due to case circumstances. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history did not indicate a lot specific quality issue. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

 
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Brand NameARMADA 14 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
BERINGEN, SWITZERLAND REG# 9710478
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula , CA 92591-4628
9519143996
MDR Report Key5000284
Report Number2024168-2015-04583
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/09/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2015
Device Catalogue NumberA2015-120
Device LOT Number766886
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 Received08/27/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2012
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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