MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Model Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the steerable guide catheter (sgc) leak during preparation.It was reported that during functional testing of the steerable guiding catheter (sgc), it was observed that the hemostatic valve didn't hold the water column.It seemed that the valve had a leak.Troubleshooting with different stopcock's was performed; however, did not work.The procedure was successfully completed with a new sgc.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned.The lot history record and similar complaint review was not performed because lot information was not provided.Based on available information and without a device to analyze, a cause for the reported leak could not be determined.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11615521
• MDR Text Key: 245092382
• Report Number: 2024168-2021-02747
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

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
• Device Operator: Health Professional
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1