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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 B1050-020
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001.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 performed to treat a non-calcified, non-tortuous left forearm fistula.The 5.0x20mm armada 35 balloon failed to deflate.After 3-5 minutes of attempting to deflate, the balloon partially deflated and was removed.A new unspecified balloon was used to successfully continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
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 other incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Without having the device to examine, the investigation was unable to determine a conclusive cause for the reported deflation difficulty.D10, h3 - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.
 
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Brand Name
ARMADA 35 PTA CATHETER
Type of Device
PERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key9335517
MDR Text Key177248701
Report Number2024168-2019-13674
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08717648154591
UDI-Public08717648154591
Combination Product (y/n)N
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2020
Device Model NumberB1050-020
Device Catalogue NumberB1050-020
Device Lot Number70505G1
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/04/2019
Initial Date FDA Received11/18/2019
Supplement Dates Manufacturer Received01/07/2020
Supplement Dates FDA Received01/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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