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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 B1070-040
Device Problems Entrapment of Device (1212); Product Quality Problem (1506); Material Rupture (1546); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2021
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for evaluation. 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 to treat a 90% stenosed, heavily calcified and heavily tortuous vessel in the brachial artery. The 7. 0x40mm armada 35 percutaneous transluminal angioplasty (pta) catheter was soaked and prepared (air aspiration) outside the anatomy prior to use, however, the balloon ruptured during inflation that was first expanded at 10 atmospheres (atms) then slowly expanded to 14 atms. There was no resistance during advancement but there was resistance during removal. The balloon was noted to be attached to the catheter which had separated from the rest of the device and the physician tried to remove the balloon by using various tension and pulling slowly but failed. The pta catheter was removed with surgical therapy. After making an incision to remove the ruptured balloon/catheter from the arteriovenous fistula near the wrist, the balloon was removed surgically. The catheter was noted to be rough and the balloon split in half. Reportedly, there was a clinically significant delay in the procedure due to the surgical intervention. It took about 2 hours and it was removed successfully. There was no major abnormality in the patient's condition. 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 Key13018585
MDR Text Key282338219
Report Number2024168-2021-11672
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1070-040
Device Catalogue NumberB1070-040
Device Lot Number10408G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2021
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: 12/16/2021 Patient Sequence Number: 1
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