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

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.

• 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 Key: 15069963
• MDR Text Key: 301917648
• Report Number: 2024168-2022-07969
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 08717648013386
• UDI-Public: 08717648013386
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934624
• Number of Events Reported: 1
• 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 Date: 03/31/2024
• Device Model Number: 23245
• Device Catalogue Number: 23245
• Device Lot Number: 60360813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/20/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1