MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ACCESSORIES; WIRE, GUIDE, CATHETER

Model Number	1003330
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat a coronary artery.A guidewire introducer was used to assist in advancing the guide wire and balloon to the lesion site.After connecting the guide wire introducer to the copilot, continuous external blood leakage from the valve was observed, rendering it unusable.A new hemostasis valve was immediately replaced to continue the procedure.This incident prolonged the procedure time however as there was no adverse patient effect the delay is not considered clinically significant.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.A review of the complaint history of the reported lot revealed no similar complaints from this lot.However, the reported leak / splash issue appears to be related to a potential product quality issue.The investigation determined the reported leak / splash appear to be a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott will continue to trend the performance of these devices.

• Brand Name: ACCESSORIES
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 22860365
• Report Number: 2024168-2025-08804
• Device Sequence Number: 12675178
• Product Code: DQX
• UDI-Device Identifier: 08717648013980
• UDI-Public: (01)08717648013980(17)260831(10)60586785
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K950752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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: 08/31/2026
• Device Model Number: 1003330
• Device Catalogue Number: 1003330
• Device Lot Number: 60586785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown