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

Catalog Number	22295-115
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2018
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.Estimated date of event.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 likely that the devices were not properly aligned while attempting to connect thus resulting in the reported loose connection and ultimately resulting in the reported leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the seal of the rotating hemostatic valve was loose and a leak was noted.The procedure was successfully completed with the same device.There was no clinically significant delay in the procedure and no adverse patient effects.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: 7366976
• Report Number: 2024168-2018-02126
• Device Sequence Number: 16153153
• Product Code: DQX
• UDI-Device Identifier: 08717648079627
• UDI-Public: 08717648079627
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K950752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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 Expiration Date: 09/30/2019
• Device Catalogue Number: 22295-115
• Device Lot Number: 60089845
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1