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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 B1080-040
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/13/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. 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 procedure was to treat a heavily calcified and occluded lesion located in the right iliac artery. The armada 35 percutaneous transluminal angioplasty catheter was advanced to the lesion but the balloon ruptured during the second inflation at nominal pressure. During removal, the device met resistance with the guide wire and both were removed as a single unit. When the balloon was inspected, it was observed that the balloon separated and a marker was missing. It is assumed the separated piece of balloon and marker that separated remained in the sheath, as there was no evidence that anything was left in patient. The procedure was aborted with no further treatment. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Visual analysis was performed on the returned device. The reported balloon rupture and separation were confirmed. The difficulty removing was not tested due to the condition of the device. It was reported that the lesion site was heavily calcified and occluded which likely contributed to the rupture. The difficulty removing and separation likely occurred due to the ruptured balloon material catching on the sheath during removal. The investigation determined that the reported difficulties were due to case circumstances. 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 from this lot. 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 Key7508680
MDR Text Key108162907
Report Number2024168-2018-03514
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,Followup
Report Date 06/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue NumberB1080-040
Device Lot Number61003G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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