MAUDE Adverse Event Report: AV-TEMECULA-CT GUIDE WIRE ACCESSORY KIT; ACCESSORIES

Catalog Number	22295-115
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.It is possible that the devices were not properly connected resulting in the reported loose connection (rotating valve becoming unscrewed/opened by itself) thus resulting in the reported leak; however, this could not be confirmed.The investigation determined a conclusive cause for the reported difficulties could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that a rotating hemostatic valve (rhv) was noted to be leaking and the rotating valve became unscrewed/opened by itself.There were no reported adverse patient effects or a clinically significant delay in the procedure.No additional information was provided.

• Brand Name: GUIDE WIRE ACCESSORY KIT
• Common Device Name: ACCESSORIES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7622008
• Report Number: 2024168-2018-04713
• Device Sequence Number: 16747306
• Product Code: DQX
• UDI-Device Identifier: 08717648079627
• UDI-Public: 08717648079627
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K950752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

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 Catalogue Number: 22295-115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1