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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 B1070-040
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Patient Problems Pain (1994); Numbness (2415); Vascular Dissection (3160); Thrombosis/Thrombus (4440)
Event Date 07/22/2021
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The udi is unknown due to the part/lot number was not provided.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the moderately calcified, mildly tortuous right common iliac artery. A 7x40mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced without resistance, and the balloon ruptured during the first inflation at nominal pressure. During removal, the pta catheter got stuck with an unspecified sheath. A piece of the balloon and shaft separated and remained on the unspecified guide wire, so a snare was used to successfully remove the separated portion. Another 7x40mm armada 35 pta and an unspecified stent were used without issue. The patient felt pain and cold [numb] in the leg, and an occlusion was noted in the common femoral artery with dissection and thrombus. An endarterectomy surgery was performed to treat them. There was a 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 Key12331591
MDR Text Key266890845
Report Number2024168-2021-07205
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1070-040
Device Catalogue NumberB1070-040
Device Lot Number10528G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/28/2021
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: 08/17/2021 Patient Sequence Number: 1
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