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

Model Number	23245
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is estimated.The customer reported the device was discarded.Investigation is not yet complete.A follow-up will be submitted with all relevant information.
Event or Problem Description
It was reported that the rotating hemostatic valve (rhv) draws air.There was no reported device use or patient involvement.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
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 device was not fully connected and/or the device seals were not fully tightened/closed 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.
Event or Problem Description
It was reported that the rotating hemostatic valve (rhv) draws air.There was no reported device use or patient involvement.There was no reported clinically significant delay in the procedure.Subsequent to the initially filed report the following information was provided: one device was in the rhv when it was leaking.A new rhv was used to complete the procedure.There were no adverse patient effects.No additional information was provided.

• Brand Name: ROTATING HEMOSTATIC VALVE
• Common Device Name: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12168225
• Report Number: 2024168-2021-06038
• Device Sequence Number: 4198690
• Product Code: DYB
• UDI-Device Identifier: 08717648013386
• UDI-Public: 08717648013386
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K934624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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
• Operator of Device: Health Professional
• Device Model Number: 23245
• Device Catalogue Number: 23245
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1