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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 B1120-060
Device Problems Off-Label Use; Material Rupture; Material Separation
Event Date 11/14/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. User facility medwatch. Uf/ importer reporter # (b)(4) - [(b)(4)].

 
Event Description

It was reported that during a left upper extremity arteriovenous graft, left subclavian vein angioplasty and stenting procedure, the balloon of a 12 x 60 mm armada 35 percutaneous transluminal angioplasty (pta) balloon catheter ruptured. The tip of the pta balloon catheter separated and the tip was successfully retrieved with a snare device via the axillary vein. There was no reported adverse patient sequela and no clinically significant delay in the procedure. No additional information was provided.

 
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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 Key8209890
Report Number2024168-2019-00018
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB1120-060
Device LOT Number80621G1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/29/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2018
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: 01/02/2019 Patient Sequence Number: 1
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