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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 B2080-060
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 04/12/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: visual analysis was performed on the returned device. The reported balloon rupture and separation was confirmed. The difficulty removing was not tested due to the condition of the device. Cine images were provided and reviewed by an abbott vascular clinical specialist who states: although tortuosity and calcification were reported, the two still images provided were insufficient to determine if these contributed to the failure. One still image documents the presence of residual contrast and a portion of the balloon catheter in the target anatomy following balloon rupture and attempted removal of the device. 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 identified no other incidents. The investigation determined that the reported difficulties and subsequent treatment was likely due case circumstances. It is likely that the balloon interacted with the moderate to severe calcification causing damage to the outer surface of the balloon material which subsequently ruptured during inflation. Additionally, the difficulty removing, and separation was the result of the ruptured balloon material catching on the introducer sheath. As force was applied during removal, the balloon and inner member separated while being pulled into the introducer sheath. 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 lesions in the common iliac and external iliac just past the internal iliac bifurcation with moderate to severe calcification and 50-70% stenosis. No resistance was noted during advancement and balloon angioplasty was attempted with the armada 35 percutaneous transluminal angioplasty (pta) catheter. The balloon was inflated once to 10 atmospheres and ruptured. When the device was attempted to be removed negative pressure was held, and the balloon was stuck in the anatomy. The catheter was able to be removed from the sheath with force; however, the balloon came off the catheter and remained in the vessel. A stent was used to embed the balloon where it was located. The patient is stable. There were no adverse patient sequela and there was 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 Key8566276
MDR Text Key143600184
Report Number2024168-2019-03424
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Catalogue NumberB2080-060
Device Lot Number80808G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2018
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: 04/30/2019 Patient Sequence Number: 1
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