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

Catalog Number 1003330

Device Problems Leak/Splash (1354); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The four additional guide wire accessory kit with copilots are being filed under separate medwatch reports.

Event Description

Reportedly, it was stated that five guide wire accessory kit with copilots had bad rotation.Additionally, the copilots leaked.The procedure was successfully completed with a new copilot.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned to abbott vascular (av) and analysis confirmed the reported difficulty in rotating the connection portion.The device was pressurized to 400 psi and no leaks were detected.Av reviewed the lot history record and there were no manufacturing nonconformities found with this lot.Additionally, a review of the complaint history identified one similar incident from this lot.Based on an expanded investigation and further review of the complaint handling database and other sources of nonconformity data, it was determined that the devices performance with regards to the difficulty rotating the connection was not related to a manufacturing issue, but due to normal variation found in manufacturing.The performance of these devices will continue to be monitored.

• 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: 6765289
• MDR Text Key: 81904192
• Report Number: 2024168-2017-06385
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 1003330
• Device Lot Number: 60032284
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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