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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 B1060-040
Device Problems Kinked (1339); Difficult to Remove (1528); Material Rupture (1546); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/13/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a de novo lesion in the non-tortuous, mildly calcified, popliteal artery with a 6. 00 x 40 mm armada 35 armada 35 percutaneous transluminal angioplasty (pta) catheter. The pta catheter was advanced to the lesion and upon the first inflation the balloon ruptured, tore, and kinked. During removal from the anatomy, the pta catheter would no longer fit into the 5f sheath. The 5f sheath was removed and a 6f sheath was carefully advanced over the pta catheter. The pta catheter was removed from the anatomy together with the 6f sheath. The procedure was stopped at that point. No additional information was provided.
 
Manufacturer Narrative
(b)(4). A visual inspection was performed and the reported balloon rupture and kink were confirmed. The reported difficulty to remove and balloon tear were unable to be confirmed due to the condition of the device. Additionally, the outer and inner member were separated. Follow-up with the site was performed and identified that the portion with the hub was intentionally removed to facilitate the removal of the 5f sheath and the advancement of the 6f sheath over 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 similar incidents reported from this lot. The investigation was unable to determine a conclusive cause for the reported balloon rupture. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
Subsequent to filing the initial mdr, the following additional information was received: the pressure of the first inflation was about 4 atmospheres (atm) when the balloon ruptured, tore, and the shaft kinked where the proximal end of the balloon is attached. No additional information 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 Key7635838
MDR Text Key112272582
Report Number2024168-2018-04987
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
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 08/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Catalogue NumberB1060-040
Device Lot Number71013G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2017
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: 06/25/2018 Patient Sequence Number: 1
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