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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
Model Number B1070-040
Device Problems Product Quality Problem (1506); Difficult to Remove (1528); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/09/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device was not returned for analysis. It is likely that the balloon twisting and rupture was the result of interaction with the lesion which was reported as heavily calcified and 100% stenosed. The difficulty encountered during removal was due to the ruptured balloon catching on the introducer sheath. 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 investigation determined that the reported difficulties were due to case circumstances. 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 an armada 35 dilatation catheter was advanced to the femoral artery, heavily calcified, 100% stenosed lesion. Inflation was attempted; however, the balloon had become twisted and burst at rated burst pressure. During device removal, it was not possible to remove the device though the 6 french guide catheter. The guide catheter was replaced with a 9 french sheath and the armada 35 was removed. About a 1-hour delay occurred without any reported clinical symptoms. Per physician, the heavily calcified lesion caused the balloon to burst. There were no adverse patient sequele. There was 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 Key6698791
MDR Text Key79569242
Report Number2024168-2017-05743
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
Report Date 07/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model NumberB1070-040
Device Catalogue NumberB1070-040
Device Lot Number70111G1
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 Received06/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2017
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: 07/10/2017 Patient Sequence Number: 1
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