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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number A2030-120
Device Problems Off-Label Use (1494); Failure to Advance (2524); Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/08/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The supera stent is filed under a separate medwatch report number.

 
Event Description

It was reported the procedure was to treat the right superficial femoral artery (sfa) with short chronic total occlusion. A 6f sheath was used. The vessel was 6 mm and laser atherectomy was performed. A 6. 0x120 mm supera self-expanding stent (ses) was advanced to the lesion without resistance and deployed. Fluoroscopy was used to confirm the stent had fully emerged/deployed when removing the delivery system. However, when a balloon was being advanced for post dilatation, the stent seemed blocked and it was observed that the supera tip had separated and was stuck at the proximal entry of the supera stent. The sheath that was already in the anatomy was advanced to capture the tip but also removed the implanted stent. No additional stent was implanted. Manual pressure was used to complete the procedure. There were no adverse patient effects and there was no reported clinically significant delay in the procedure. Return device analysis noted that the 6f sheath was returned with a 3. 0 armada 14 balloon catheter inserted inside. It appears that the balloon had been inflated and was likely used to help remove the separated tip and subsequently the implanted stent. It was confirmed that there was no device issue with the armada balloon. Additional information was received: the sfa was pre-dilated with a 6. 0 balloon prior to deployment of the supera ses. There was no reported resistance removing the supera stent system. Angiography showed good wall apposition and no post-dilatation was needed. The 3. 0 armada balloon was advanced to possibly treat the tibial artery, but could not cross and it was observed via additional imaging that the tip of the supera ses had detached and was blocking the proximal end of the supera stent. The 3. 0 armada balloon was then used to retrieve the tip of the supera ,and inadvertently removed the implanted stent. No additional treatment was performed, and no additional stent was implanted. No additional information was provided.

 
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Brand NameARMADA 14 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
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key10670949
MDR Text Key211318634
Report Number2024168-2020-08533
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK102705
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 11/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberA2030-120
Device Catalogue NumberA2030-120
Device LOT Number0060941
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/16/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/09/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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