MAUDE Adverse Event Report: AV-TEMECULA-CT ROTATING HEMOSTATIC VALVE; ACCESSORIES

Catalog Number	23245
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The additional rotating hemostatic valve is being filed under a separate medwatch report#.Evaluation summary: the device was returned for analysis.Visual, dimensional, and functional inspections were performed on the returned device.The leak and device operates differently then expected were not 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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left anterior descending artery and diagonal artery.It was reported that two rotating hemostatic valves (rhv) were attempted to be used in the case; however, when the valves were turned they did not tighten on the guide wire; which, caused leaking.A new rhv was used to complete the case.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

• Brand Name: ROTATING HEMOSTATIC VALVE
• Common Device Name: ACCESSORIES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6477277
• Report Number: 2024168-2017-02983
• Device Sequence Number: 1199077
• Product Code: DYB
• UDI-Device Identifier: 08717648013386
• UDI-Public: (01)08717648013386(17)181231(10)60038283
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2017

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: 12/31/2018
• Device Catalogue Number: 23245
• Device Lot Number: 60038283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2017
• Initial Report FDA Received Date: 04/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 92