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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR COPILOT® BLEEDBACK CONTROL VALVE; ACCESSORIES

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ABBOTT VASCULAR COPILOT® BLEEDBACK CONTROL VALVE; ACCESSORIES Back to Search Results
Catalog Number 1003331
Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2023
Event Type  malfunction  
Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional copilot devices referenced in b5 are filed under separate medwatch report numbers.Na.
 
Event Description
It was reported that the procedure was to treat a lesion in an unspecified artery.The indeflator was attempted to be used, however, a failure with the device valve was reported resulting in blood leakage.Three other indeflators from the same lot had the same issue of blood leakage.Another indeflator with a different lot was used to complete the procedure.There was no reported adverse patient effect and there was no reported clinically significant delay in the procedure.No additional information was provided.
 
Event Description
It was reported that the procedure was to treat a lesion in an unspecified artery.The indeflator was attempted to be used, however, a failure with the device valve was reported resulting in blood leakage.Three other indeflators from the same lot had the same issue of blood leakage.Another indeflator with a different lot was used to complete the procedure.There was no reported adverse patient effect and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the complaint device is a copilot and the device could not maintain the attachment due to loose connection with an unknown device.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 did not indicate a lot specific quality issue.It is possible that the devices were not properly aligned and/or not fully connected/tightened while attempting to connect and/or the port of the device being connected was compromised resulting in the reported loose/intermittent connection and ultimately resulting in the reported leak; however, as the device was not returned for analysis this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported loose/intermittent connection and the reported leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9, h3 - device returning status updated from unknown to no as the device has been retained by the hospital.
 
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Brand Name
COPILOT® BLEEDBACK CONTROL VALVE
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 Key18476639
MDR Text Key332892860
Report Number2024168-2024-00435
Device Sequence Number1
Product Code DTL
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K991102
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 02/19/2024
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 Catalogue Number1003331
Device Lot Number60459943
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/19/2023
Initial Date FDA Received01/09/2024
Supplement Dates Manufacturer Received01/26/2024
Supplement Dates FDA Received02/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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