MAUDE Adverse Event Report: ABBOTT VASCULAR GUIDE WIRE ACC.KIT W/COPILOT®; ACCESSORIES

Model Number 1003330

Device Problem Leak/Splash (1354)

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

Event Date 07/03/2022

Event Type  Injury  

Manufacturer Narrative

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 possible that the clamp seal was not entirely closed; thus resulting in the reported leak; however as the device was not returned for analysis this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The treatment appears to be related to the operational context of the procedure as the y-connector had to be held throughout the procedure in order to stop the leakage.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that during the procedure, there was leakage in the y-connector of the copilot.The y-connector had to be held throughout the procedure in order to stop the leakage.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: GUIDE WIRE ACC.KIT W/COPILOT®
• 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: 15117124
• MDR Text Key: 296753440
• Report Number: 2024168-2022-08259
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013980
• UDI-Public: 08717648013980
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K991102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 1003330
• Device Catalogue Number: 1003330
• Device Lot Number: 60359636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2022
• 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
• Patient Outcome(s): Required Intervention