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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 B1120-040
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2020
Event Type  Injury  
Manufacturer Narrative

The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot revealed no indication to suggest a lot specific product quality issue. Based on the information provided, it is likely that the reported resistance during advancement resulting in failure to cross and balloon rupture was the result of interaction with the challenging anatomy. Additionally, it is likely that during removal, the ruptured balloon material caught on the introducer sheath and separated. The surgical procedure to remove the separated portion of the balloon was related to circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

 
Event Description

It was reported that the procedure was to treat a de novo lesion in the anastomotic part of right pulmonary artery. The 12x40mm armada 35 balloon dilatation catheter (bdc) was advanced over a 0. 035¿ non-abbott guide wire for dilatation. The bdc met resistance with anatomy and failed to cross. The bdc was removed and the guide wire was replaced with a non-abbott stiff guide wire. The balloon was slightly re-shaped to a banana shape due to the stenosis and tortuosity of the target lesion before being re-advanced. The bdc reached the target lesion; however, the balloon ruptured during second inflation at an unspecified pressure but below the rated burst pressure. During removal of the bdc, resistance with the introducer sheath was felt and the balloon part separated from the shaft. A cut-down procedure was performed to successfully remove the separated portion. There was no adverse patient sequela reported and no significant delay in the procedure reported. 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 Key9998171
MDR Text Key189080753
Report Number2024168-2020-03900
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberB1120-040
Device Catalogue NumberB1120-040
Device LOT Number90628G1
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 Received04/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/28/2019
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: 04/24/2020 Patient Sequence Number: 1
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