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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 B1080-040
Device Problems Improper or Incorrect Procedure or Method (2017); Material Too Soft/Flexible (4007)
Patient Problem Intimal Dissection (1333)
Event Date 05/15/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 performed to treat a atrioventricular fistula (avf). The 8x40mm armada 35 balloon was pressurized to 18 atmospheres (atm) but the waist would not resolve. The device was replaced with an 8x40mm non-abbott high pressure balloon. The waist opened at 23 atm. The completion angiogram showed extravasation of contrast. The physician was uncertain if the armada 35 caused or contributed to the dissection. An 8x40mm non-abbott covered stent was deployed and post-dilated with an unspecified 8mm balloon. The completion angiogram showed a widely patent avf with brisk flow of contrast. There was no further leak from the vein. There were no adverse patient effects and no clinically significant delay in the procedure. 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 Key10168565
MDR Text Key195585385
Report Number2024168-2020-05139
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 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1080-040
Device Catalogue NumberB1080-040
Device Lot Number00205G1
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 Received07/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/05/2020
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: 06/18/2020 Patient Sequence Number: 1
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