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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number A2020-120
Device Problems Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)
Patient Problems Aneurysm (1708); Hematoma (1884); Pain (1994); No Consequences Or Impact To Patient (2199)
Event Date 07/31/2018
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 relevant information.
 
Event Description
It was reported that the balloon of a 2. 0mm x 120mm armada 14 pta balloon catheter ruptured. On removal of the pta balloon catheter, it was noted that balloon material remained within the patient anatomy. The separated balloon material was retrieved. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual inspections were performed on the returned device. The reported balloon rupture and separation was confirmed. The resistance was not confirmed as it was based on case circumstances. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot revealed no other incidents. The reported patient effects hematoma and pain of are listed in the armada 14 percutaneous transluminal angioplasty (pta) balloon catheter instructions for (ifu) as complications may occur as a result of pta. Based on the information provided and analysis of the returned device, the reported difficulties and subsequent treatment/therapy appear to be due to operational circumstances of the procedure. It is likely that the resistance during advancement and rupture occurred due to interaction with lesion calcification or associated devices causing damage to the outer surface of the balloon. The additional damage stretched/separated portion of the balloon and inner member likely occurred as the ruptured balloon material catching on the introducer sheath during removal. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
Subsequent to the initially filed report, the following information was received: the procedure was performed to treat a totally occluded lesion in the posterior tibial artery with no tortuosity. The 2. 0 x 120 mm armada 14 percutaneous transluminal angioplasty (pta) balloon catheter was advanced to the lesion with resistance from the anatomy. Multiple inflations to 8 atmospheres of the balloon were made. Following the balloon rupture, the pta balloon catheter was withdrawn into the 6f sheath and an additional unspecified balloon catheter was advanced parallel to trap the separated balloon material in the sheath. The sheath and balloon catheters were then removed as a single unit. Post procedure, the patient developed a progressive aneurysm and a painful hematoma in the calf. No treatment was performed for the aneurysm as it occluded spontaneously and the hematoma was managed conservatively. No additional information was provided.
 
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Brand NameARMADA 14 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)
CLONMEL, IRELAND REG# 9616693
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 Key7803295
MDR Text Key117829194
Report Number2024168-2018-06459
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K102705
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 11/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Catalogue NumberA2020-120
Device Lot Number8041741
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2018
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: 08/21/2018 Patient Sequence Number: 1
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