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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
Catalog Number UNK ARMADA 35
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation (2001)
Event Date 02/19/2020
Event Type  Injury  
Manufacturer Narrative
Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated. 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.
 
Event Description
It was reported that the procedure was to treat the right posterior tibial artery. A 2. 0x200 mm armada percutaneous transluminal angioplasty (pta) catheter was advanced and used for angioplasty of the posterior tibial artery. The catheter was inflated to 14 atmospheres for 2 minutes. The armada was removed and angiography was performed, showing flow through the posterior tibial artery; however, a perforation was noted as well. The armada was re-advanced and prolonged inflation for 12 minutes was performed; however, extravasation of contrast was still noted. Prolonged inflation was performed a second time. As the patient was determined to not be a surgical candidate, it was decided to implant a 2. 80x16 mm graftmaster covered stent. The stent was deployed at 16 atmospheres and the perforation was sealed. The use of the graftmaster covered stent did not cause or contribute to any adverse patient effects or complications. 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 Key9871682
MDR Text Key187730172
Report Number2024168-2020-02782
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK ARMADA 35
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2020
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: 03/24/2020 Patient Sequence Number: 1
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