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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 Insufficient Information (4580)
Event Date 02/19/2021
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for investigation. 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 performed to treat restenosis of the previously implanted non-abbott stent in the heavily calcified and moderately tortuous right common iliac artery. An 8. 0 x 40 mm armada 35 pta balloon dilatation catheter (bdc) was being inflated for the second time as part of the in-stent stenosis treatment; however, the balloon ruptured circumferentially at 14 atmospheres. The distal balloon material remained attached to the bdc and an attempt was made to remove the bdc through the 7fr introducer sheath. The distal part of the balloon met resistance at the tip of the sheath and could not be removed through the sheath with the rest of the bdc. Therefore, cutdown surgery was performed and the balloon tip was retrieved from the patient's anatomy. A 9. 0 x 39 mm omnilink elite stent was then deployed to treat the restenosis. A delay in the procedure was reported. The patient was discharged three days after the procedure with no reported adverse patient sequela. 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 Key11456741
MDR Text Key239059338
Report Number2024168-2021-01916
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
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 Number01013G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2020
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: 03/10/2021 Patient Sequence Number: 1
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