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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 B1060-100
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/29/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number e2019001. 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.
 
Event Description
It was reported that the procedure was to treat a heavily calcified lesion in the significantly narrowed left superficial femoral artery. The armada 35 percutaneous transluminal angioplasty (pta) catheter was being used for post-dilatation of an absolute stent. The balloon was inflated once to 13 atmospheres and ruptured and separated from the catheter. During withdrawal of the ruptured balloon, some resistance was noted at the tip of the sheath. The patient was sent to surgery and the separated portion was removed. 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 Key9356494
MDR Text Key167649619
Report Number2024168-2019-13808
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUK
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 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model NumberB1060-100
Device Catalogue NumberB1060-100
Device Lot Number70306G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2017
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: 11/21/2019 Patient Sequence Number: 1
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