MAUDE Adverse Event Report: ABBOTT VASCULAR GUIDE WIRE ACCESSORY KIT; ACCESSORIES

Model Number 22295-115

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3- date of event: estimated.The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the lot number was not provided.It is possible that the guide wires were not coaxially aligned during insertion thus resulting in the reported difficult to advance; however this cannot be confirmed.Additionally, it is possible the devices were not fully tightened/closed resulting in the reported loose or intermittent connection and the reported leak; however as the device was not returned for analysis this cannot be confirmed.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 manufacture, design or labeling.

Event Description

It was reported in a general comment that the guide wire accessory kit with 115 rhv (rotating hemostatic valve) was noted to not close properly, not achieving complete hemostasis and blood comes out.Also when the valve is completely open, it is very difficult to pass two 0.014 guide wires through since there's resistance when advancing two at once.However, the the procedure was finished with the same rhv.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: GUIDE WIRE ACCESSORY KIT
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17277981
• MDR Text Key: 318572501
• Report Number: 2024168-2023-07184
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K950752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22295-115
• Device Catalogue Number: 22295-115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 0.014 GUIDE WIRE.