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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number B1080-040
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/02/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. The balloon rupture and separation were confirmed via photos provided by the account. 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 complaints. Based on the information provided, the balloon rupture, separation and difficult to remove appear to be due to case circumstances. It is likely that the balloon rupture, difficult to remove, and subsequent separation occurred due to interaction with anatomical structures or other devices within the anatomy or as a result of the use of a non pressure monitored inflation device. The additional therapy to remove the separated portion was due to the 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 the procedure was performed to treat an atrioventricular fistula with mild tortuosity and 80% stenosis. An 8 x 40mm armada 35 balloon dilation catheter (bdc) was prepped without any issues and advanced to the target lesion without any resistance; however, while attempting to inflate the balloon of the bdc, the balloon ruptured after two inflations at an unknown pressure. It was noted that the physician inflated the balloon by hand; therefore, it is unknown if the balloon was inflated beyond nominal pressure. While attempting to remove the balloon, resistance was noted with the anatomy and a portion of the balloon detached and remained in the anatomy. A snare device was then inserted, and the detached pieces were successfully retrieved from the anatomy. There was no reported clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameARMADA 35 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key10857252
MDR Text Key216836577
Report Number2024168-2020-09651
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
Type of Report Initial,Followup
Report Date 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1080-040
Device Catalogue NumberB1080-040
Device Lot Number00527G1
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 Received11/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2020
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: 11/17/2020 Patient Sequence Number: 1
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