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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 B1070-120
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/26/2021
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. The additional armada 35 device referenced is filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was performed to treat a lesion with heavy calcification, moderate tortuosity, and 80% stenosis in the femoral artery. Reportedly, a 6. 0 x 100 mm armada 35 balloon dilatation catheter (bdc) was advanced for dilatation; however, resistance was felt due to the anatomy and the balloon ruptured during first inflation at nominal pressure. During removal, resistance was noted with the sheath and the distal part of the balloon separated and remained in the artery. An absolute stent was deployed to cover (embed) the separated balloon material to avoid distal embolization. A new 7. 0 x 120 mm armada 35 bdc was then advanced to expand the stent but the balloon ruptured during the first inflation at nominal pressure. On removal, resistance was noted with the sheath and the distal part of the balloon separated and remained in the artery. Another absolute stent was deployed to cover (embed) the separated balloon material. An unspecified bdc was then used and the target lesion was treated. There were no adverse patient sequela and no 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 Key11477783
MDR Text Key239675060
Report Number2024168-2021-02006
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeFR
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 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1070-120
Device Catalogue NumberB1070-120
Device Lot Number00622G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2020
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: 03/12/2021 Patient Sequence Number: 1
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