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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1014256-200
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/06/2015
Event Type  Malfunction  
Event Description

It was reported that the procedure was to treat a lesion in the mid left superficial femoral artery with mild calcification. The 5. 0 x 200 mm armada 18 balloon catheter was advanced and inflated 5 times to rated burst pressure (rbp); however, it was observed that the proximal balloon shoulder extended farther than expected from the proximal balloon marker. The procedure was then completed. There were no adverse patient effects and no clinically significant delay in the procedure. 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. A review of the lot history record revealed no non-conformances that would have contributed to the reported event. A query of the electronic complaint handling database revealed no other similar incidents reported from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling. The armada 18 is currently not commercially available in the u. S. ; however, it is similar to a device sold in the u. S.

 
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Brand NameARMADA 18 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer (Section G)
CLONMEL, IRELAND REG# 9616693
abbott vascular
26531 ynez road
temecula CA 92591 462
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key4806268
MDR Text Key16179648
Report Number2024168-2015-03034
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK121352
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial
Report Date 05/06/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2017
Device Catalogue Number1014256-200
Device LOT Number5033141
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/06/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/29/2015 Patient Sequence Number: 1
Treatment
SHEATH: 6F TERUMO DESTINATION
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