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 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The other copilot device is filed under a separate mfr number.

Event Description

It was reported that the procedure was to treat an 80-90% stenosed lesion in the mildly tortuous saphenous vein graft (svg) to diagonal artery.During the procedure, air bubbles were observed in the copilot.The co-pilot was exchanged and air bubbles were noted in that copilot as well.A third copilot was used to successfully complete the procedure.No air was noted in the patient and the patient did not experience any adverse events or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported leak was unable to be confirmed.During device analysis, the device worked as intended.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.As the reported leak was unable to be confirmed during return analysis, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the valve was not entirely closed; thus resulting in the reported leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 12840606
• MDR Text Key: 283302352
• Report Number: 2024168-2021-10623
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013980
• UDI-Public: 08717648013980
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K991102
• 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,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1003330
• Device Catalogue Number: 1003330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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