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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 UNKNOWN COPILOT BBC
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/20/2022
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a lesion in the popliteal artery.The co-pilot bleedback control valve was used in a the procedure with a jeti thombectomy device.The thrombectomy device was noted low pressure error code due to a leak in the co-pilot valve.There was no adverse patient effect and no clinically significant delay reported in the procedure.The co-pilot was replaced to continue the procedure.No additional information was provided.
 
Manufacturer Narrative
The unique device identifier (udi) is unknown because the part number and 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 part and lot number was not provided.It is possible that the connections and/or 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.
 
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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 Key15788689
MDR Text Key303573055
Report Number2024168-2022-11538
Device Sequence Number1
Product Code DTL
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
Report Date 11/14/2022
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 Catalogue NumberUNKNOWN COPILOT BBC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/20/2022
Initial Date FDA Received11/14/2022
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
Patient Age65 YR
Patient SexMale
Patient Weight91 KG
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