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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number B2060-200
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

 
Event Description

It was reported that the armada 35 was inserted to the mild to moderately calcified lesion in the superficial femoral artery and inflated to 6 atmospheres with a non-abbott inflation device, but the armada 35 did not hold pressure. Contrast was seen leaking where the purple and black colors meet on the shaft of the armada 35 outside the anatomy. The armada 35 was removed from the anatomy and replaced with an armada 18. The armada 18 was used with the same inflation device and the procedure was successfully completed. There were no adverse patient effects from the armada 35 device issue. No additional information was provided.

 
Manufacturer Narrative

(b)(4). Evaluation summary: the returned device analysis identified a leak in the distal end of the strain relief, which was found when the balloon catheter was pressurized. A search of the complaint handling database was performed and no other incidents were identified from this lot for hub leaking issues. While a search of the lot history record for this specific lot indicated no related non-conformance records, based on an expanded investigation, a product issue related to leakage at the hub was identified. The event was possibly related to hub assembly during manufacturing. Further assessment of this issue per site operating procedures was performed and corrective/preventive actions to address this issue have been implemented. The performance of these devices will continue to be monitored.

 
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Brand NameARMADA 35 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)
EL COYOL, COSTA RICA REG# 3009031392
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 Key5296105
MDR Text Key33901564
Report Number2024168-2015-07565
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/04/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/14/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2018
Device Catalogue NumberB2060-200
Device LOT Number50609G1
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/02/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2015
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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