MAUDE Adverse Event Report: ABBOTT VASCULAR RHV 115; ACCESSORIES

Catalog Number	23245
Medical Device Problem Codes	Product Quality Problem (1506); Unstable (1667)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The two additional rotating hemostatic valves (rhv) devices referenced are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that before use, the o-rings of three rotating hemostatic valves (rhv) were noted to be unstable.Therefore, a copilot was used instead to successfully complete the procedure.There was no patient involvement.No additional information provided.Returned device analysis revealed that the cap of the rhv leaked.
Additional Manufacturer Narrative
The device was returned for analysis.The reported product quality problem irregular appearance/ o-ring was able to be confirmed however after further investigation it was determined to be in specification.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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.After further investigation it was determined to be in specification.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: device code 1667 was removed.

• Brand Name: RHV 115
• Common Device Name: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9322454
• Report Number: 2024168-2019-13570
• Device Sequence Number: 14046690
• Product Code: DYB
• UDI-Device Identifier: 08717648013386
• UDI-Public: 08717648013386
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K934624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: 02/28/2021
• Device Catalogue Number: 23245
• Device Lot Number: 60177549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1