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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 B1100-060
Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/23/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a soft tissue tract for gastrostomy tube placement. The 10x60mm armada 35 balloon dilatation catheter ruptured at an unknown pressure during the first inflation. During removal resistance was felt with the device and the tip separated approximately 1cm. Fluoroscopy revealed the tip freely moving in the gastrum as well as intragastrical position of tube. It was noted the small tip fragment would pass without patient sequelae. There was no clinically significant delay 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 Key14704226
MDR Text Key294130932
Report Number2024168-2022-06444
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1100-060
Device Catalogue NumberB1100-060
Device Lot Number20216G1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/16/2022
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: 06/15/2022 Patient Sequence Number: 1
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