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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1013469-200
Device Problem Deflation Problem (1149)
Patient Problem Thrombosis (2100)
Event Date 06/04/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number (b)(4) which permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition. There may be gaps in numbering for reports submitted during the transition period. The device was received. Investigation is not yet complete. A follow-up report will be submitted with all. Additional relevant information. Na.
 
Event Description
It was reported that the procedure was to treat a left superficial femoral artery. A 5. 5x200mm armada 18 otw (over the wire) balloon dilatation catheter (bdc) was advanced to the lesion without issue and inflated once at nominal pressure. During removal, the bdc failed to deflate, several attempts were performed but unsuccessful. After 10 minutes of efforts, the balloon was able to successfully deflate. It was then noted that a clot formation on the lower leg was formed. An atherectomy catheter was used to suck the clot out. Residual clot persisted and tissue plasminogen activator medication was provided to resolve the issue. Hospitalization was prolonged due to this issue. The patient is fine. There was no adverse patient sequela reported. No additional information was provided.
 
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Brand NameARMADA 18 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
connie speck
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key8795930
MDR Text Key151219326
Report Number2024168-2019-10099
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151317
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 08/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1013469-200
Device Lot Number9011542
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2019
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: 07/16/2019 Patient Sequence Number: 1
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