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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number B2080-060
Device Problems Off-Label Use; Material Rupture
Event Date 07/05/2019
Event Type  Injury  
Manufacturer Narrative

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. Exemption number (b)(4)-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition. There may be gaps in numbering for reports submitted during the transition period.

 
Event Description

It was reported that the procedure was performed to treat a lesion in the left arteriovenous fistula. An 8x60mm armada 35 balloon catheter ruptured transversely during the second inflation at 14 atmospheres and ruptured the fistula. The fistula had to be opened and repaired surgically. There was no reported 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)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS 
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula , CA 92591-4628
9519143996
MDR Report Key8834107
Report Number2024168-2019-10414
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 10/14/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB2080-060
Device LOT Number80823G1
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 Received09/24/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/23/2018
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: 07/26/2019 Patient Sequence Number: 1
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