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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2021
Event Type  Injury  
Event Description
It was reported that during a procedure 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 pressure, the balloon ruptured with one fragment separating from the device. Resistance was noted when pulling the bdc back into the introducer sheath. Surgical intervention was required to remove balloon fragment from the patient anatomy, which was successfully removed. There was no reported adverse patient sequela. No additional information was provided.
 
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.
 
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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 Key13014690
MDR Text Key287393753
Report Number2024168-2021-11654
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 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2100-060
Device Catalogue NumberB2100-060
Device Lot Number90916G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2019
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: 12/15/2021 Patient Sequence Number: 1
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