MAUDE Adverse Event Report: AV-TEMECULA-CT GUIDE WIRE ACC.KIT W/COPILOT; HEMOSTATIC VALVE

Catalog Number 1003330

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported the copilot leaked.The device was exchanged for another copilot and the procedure completed.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Internal file number - 333003/1-1.Evaluation summary: visual and functional inspections were performed on the returned copilot.The reported leak was unable to be confirmed.It may be possible that syringe or inflation device being used was not properly connected; however, this could not be 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 revealed no other incidents.The investigation was unable to determine a cause for the reported leak.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: GUIDE WIRE ACC.KIT W/COPILOT
• Type of Device: HEMOSTATIC VALVE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7011341
• MDR Text Key: 92507633
• Report Number: 2024168-2017-08800
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K991102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 1003330
• Device Lot Number: 60050246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1