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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 Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546)
Patient Problem Death (1802)
Event Date 03/03/2017
Event Type  Death  
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 relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion located in the common iliac below the bifurcation with mild tortuosity and heavy calcification that was 75% stenosed. A 12 x 40 mm armada 35 balloon dilatation catheter (bdc) was advanced without resistance to the lesion for pre-dilatation and crossed successfully; however, the balloon ruptured during the first inflation at approximately 6 atmospheres. The balloon could not be retracted through the introducer sheath for removal and the balloon with distal part of the catheter separated and remained inside the vessel. Snaring of the separated catheter was unsuccessful, therefore an arteriotomy was performed to remove it. It was further reported that the patient was not in good condition for surgery and expired two days after surgery due to heart problems. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for analysis. It is likely that the rupture occurred due to interaction with the lesion site. The resistance during removal and separation noted in the returned analysis likely occurred when removing the catheter against resistance as the ruptured balloon material interacted with the introducer sheath. Death is listed in the armada 35 instruction for use as a potential complication that may occur as a result of percutaneous transluminal angioplasty. 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 indication of a lot specific product issue. The investigation determined the reported balloon rupture, difficulty removing, separation, surgical procedure, and removal of foreign body are related to circumstances of the procedure. A conclusive cause for the death could not be determined. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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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 Key6488976
MDR Text Key72652654
Report Number2024168-2017-03080
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2019
Device Catalogue NumberB1120-040
Device Lot Number60225G1
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 Received04/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2016
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: 04/13/2017 Patient Sequence Number: 1
Treatment
SHEATH: 6FR
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