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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
Model Number 1003331
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event is estimated.The udi # is unknown because the part/lot number were not provided.The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the lot number was not provided.It is possible that the cap seal was not entirely closed/fully tightened; thus resulting in the reported leak; however as the device was not returned for analysis 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.The additional copilot device referenced is being filed under a separate medwatch report number.
 
Event Description
It was reported that during the procedure, two copilot devices had air become trapped inside.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
N/a b3, b6- date of event updated from 8/1/2022 to: 7/29/2022.
 
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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 Key15251457
MDR Text Key305419938
Report Number2024168-2022-08896
Device Sequence Number1
Product Code DTL
UDI-Device Identifier08717648013997
UDI-Public08717648013997
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K991102
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/12/2022
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 Number1003331
Device Catalogue Number1003331
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/01/2022
Initial Date FDA Received08/18/2022
Supplement Dates Manufacturer Received08/22/2022
Supplement Dates FDA Received09/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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