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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER
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ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1014256-020
Device Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2022
Event Type  malfunction  
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 additional device is filed under a separate medwatch report number.
 
Event Description
It was reported when attempting to back load the unspecified command guide wire thru the 5.0x20mm armada 18 balloon dilatation catheter resistance was felt and the guide wire went through the balloon shaft and unspecified catheter.It was noted the balloon was being used as a support catheter and the access sheath had a sharp bend causing the balloon to become temporarily stuck in the acute bend of the access sheath.The tip of the command guide wire punctured the balloon.A new guide wire and balloon were used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay reported.No additional information was provided.
 
Manufacturer Narrative
Visual, dimensional and functional inspections were performed on the returned device.The reported kink was confirmed.The reported shaft tear, difficulty advancing the device over the guide wire and introducer sheath could not be confirmed.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 identified no other similar incidents and/or complaints from this lot.The investigation determined the reported complaints appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
Event Description
It was reported when attempting to back load the unspecified command guide wire thru the 5.0x20mm armada 18 balloon dilatation catheter resistance was felt and the guide wire went through the balloon shaft and unspecified catheter.It was noted the balloon was being used as a support catheter and the access sheath had a sharp bend causing the balloon to become temporarily stuck in the acute bend of the access sheath.The tip of the command guide wire punctured the balloon.A new guide wire and balloon were used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay reported.Subsequently to the initial being filed the operator believes the armada balloon bent/folded at sharp bend in sheath.This was the same point that the guide wire was advanced in preparation for moving onwards into the vessel.He believes tip of the command guide wire deviated at this point, but he cannot be sure.No additional information was provided.
 
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Brand Name
ARMADA 18 PTA CATHETER
Type of Device
PERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI  
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key13711212
MDR Text Key288866544
Report Number2024168-2022-02376
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1014256-020
Device Lot Number0111641
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
HT COMMAND GUIDE WIRE
Patient Age67 YR
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