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

Model Number	23245
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during an intervention, the rotating hemostatic valve (rhv) was difficult to screw tight and a leak was noted.There was no adverse patient effect and no 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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.It is possible the device was not fully connected/tightened; however as the device was not returned for analysis this cannot be confirmed.The investigation determined a conclusive cause for the reported leak cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: device code 1371-removed.

• Brand Name: ROTATING HEMOSTATIC VALVE
• Common Device Name: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11152877
• Report Number: 2024168-2021-00333
• Device Sequence Number: 19818452
• Product Code: DYB
• UDI-Device Identifier: 08717648013386
• UDI-Public: 08717648013386
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K934624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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 Expiration Date: 02/28/2022
• Device Model Number: 23245
• Device Catalogue Number: 23245
• Device Lot Number: 60232577
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1