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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 B1060-040
Device Problems Difficult to Remove ; Material Rupture; Physical Resistance
Event Date 10/23/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The 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 concentric shunt lesion with no tortuosity, heavy calcification and 90% restenosis in an unspecified lesion. The 6. 0 x 40 mm armada 35 was prepped (air aspiration) outside the anatomy prior to use. The armada 35 was advanced to the target lesion with resistance noted and during the first inflation in 10 seconds, the armada 35 balloon ruptured at 4 atmospheres (atm). The armada 35 was removed with resistance noted from the patient anatomy and exchanged with a non-abbott balloon catheter which was dilated without any issue. The procedure was successfully completed. There was no adverse patient effect. There was 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. Based on the reported information, there is no indication of a product quality issue with respect to manufacture, design, or labeling. The reported resistance and balloon appears to be due to case circumstances. A review of the lot history record revealed no non-conformances that would have contributed to the reported event. Additionally, a review of the complaint history did not indicate a lot specific quality issue. Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture or labeling.

 
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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 Key5231819
Report Number2024168-2015-06951
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/08/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/17/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2018
Device Catalogue NumberB1060-040
Device LOT Number50216G1
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 Received11/18/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2015
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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