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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR GUIDE WIRE ACC.KIT W/COPILOT®; ACCESSORIES

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ABBOTT VASCULAR GUIDE WIRE ACC.KIT W/COPILOT®; ACCESSORIES Back to Search Results
Model Number 1003330
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2023
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a lesion in an unspecified vein.When using the copilot, the valve was open as there was blood leakage with and without locking the device.Another copilot was used to complete the procedure.There was no adverse patient effect and there was 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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.It is possible that interaction with other devices inserted in the co-pilot and/or procedural contaminates (blood, contrast) resulted in the valve/seal not being able to fully/entirely close; thus resulting in the reported leak; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand Name
GUIDE WIRE ACC.KIT W/COPILOT®
Type of Device
ACCESSORIES
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 2024168
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key16521513
MDR Text Key311345168
Report Number2024168-2023-02518
Device Sequence Number1
Product Code DTL
UDI-Device Identifier08717648013980
UDI-Public08717648013980
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K991102
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 03/10/2023
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 Model Number1003330
Device Catalogue Number1003330
Device Lot Number60408886
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/17/2023
Initial Date FDA Received03/10/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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