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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 B2070-040
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2022
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation. 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 and/or complaints from this lot. The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported difficulty removing the device, balloon separation, unexpected medical intervention and removal of foreign body appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the left iliac artery. The armada 35 was advanced to the lesion and inflated but ruptured at an unknown pressure. Difficulty was noted during removal, as the balloon accordioned on the shaft. The balloon portion separated and was able to be snared. All portions of the device were removed from the patient anatomy. 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 Key14047158
MDR Text Key289261080
Report Number2024168-2022-03714
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2070-040
Device Catalogue NumberB2070-040
Device Lot Number11206G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2021
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: 04/07/2022 Patient Sequence Number: 1
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