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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 B2100-060
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/12/2021
Event Type  Injury  
Manufacturer Narrative
Date of event has been estimated. The customer reported the device is not returning. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional device referenced in is being filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat a heavily calcified re-thrombosed stent. After the 10x60mm armada 35 balloon dilatation catheter (bdc) was advanced to the lesion, and after several inflations of the balloon, between nominal pressure and above nominal, the balloon ruptured. It was noted the rupture occurred due to the previously implanted stent had fractured and caused the balloon to rupture on contact. During removal of the bdc resistance was met with the introducer and the central sheath of the balloon separated. It was noted another unspecified armada 35 bdc was advanced; however, the same exact issue occurred and bdc ruptured at an unknown pressure. Therefore, two fragments remained in the anatomy and the fragments were pressed against the vascular wall. There was no adverse patient sequela reported and no clinically significant delay reported. 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 Key13177583
MDR Text Key283323731
Report Number2024168-2022-00170
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 Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2100-060
Device Catalogue NumberB2100-060
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 01/06/2022 Patient Sequence Number: 1
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