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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 B1120-040
Device Problems Off-Label Use; Material Rupture; Difficult to Advance
Event Date 03/05/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history revealed no other incidents. The armada 35 instructions for use (ifu), states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In this case, it could not be determined if using the armada 35 off-label caused or contributed to the reported difficulties. The investigation determined that the reported difficulties appear to be related to case circumstances. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

 
Event Description

It was reported that the procedure was to treat a de novo lesion in a mildly tortuous and heavily calcified aortic artery that was 70% stenosed. A 12 x 40 mm armada 35 balloon catheter was used and met initial resistance with the anatomy. However, the balloon ruptured during its first inflation. Therefore, the device was removed and an unspecified armada 35 balloon catheter was used to successfully complete the procedure. There were no adverse patient effects 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 Key8452509
Report Number2024168-2019-02313
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB1120-040
Device LOT Number81113G1
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 Received03/05/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/01/2018
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: 03/26/2019 Patient Sequence Number: 1
Treatment
GUIDE WIRE: STORQUE .035 WIRE
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