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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ROTATING HEMOSTATIC VALVE; ACCESSORIES

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ABBOTT VASCULAR ROTATING HEMOSTATIC VALVE; ACCESSORIES Back to Search Results
Model Number 23245
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2022
Event Type  malfunction  
Event Description
It was reported that during preparation, when the rotating hemostatic valve was attached to unspecified devices, air was observed to be coming in from the valve.Therefore, the device was replaced.The same issue occurred with two more hemostatic valves.There was no patient involvement and no clinically significant delay in the procedure.A non-abbott device was used to complete the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other two rotating hemostatic valves devices referenced are filed under separate medwatch report numbers.
 
Manufacturer Narrative
The device was returned for analysis.The reported leak was unable to be confirmed.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.As the reported leak was unable to be confirmed during return analysis, it is possible that the cap seal and/or the connections were not entirely/fully tightened; 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
ROTATING HEMOSTATIC 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 Key15069963
MDR Text Key301917648
Report Number2024168-2022-07969
Device Sequence Number1
Product Code DYB
UDI-Device Identifier08717648013386
UDI-Public08717648013386
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K934624
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 08/30/2022
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 Expiration Date03/31/2024
Device Model Number23245
Device Catalogue Number23245
Device Lot Number60360813
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/01/2022
Initial Date FDA Received07/20/2022
Supplement Dates Manufacturer Received08/23/2022
Supplement Dates FDA Received08/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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