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

Model Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Na.

Event Description

This is filed to report the steerable guide catheter (sgc) leak.It was reported that during preparation of the steerable guide catheter (sgc), a loss of fluid column occurred.This issue occurred three separate times; therefore, the sgc was not used and the procedure was discontinued.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned and investigated.The reported steerable guide catheter (sgc) leak was not confirmed during return device analysis as no issues were noted during testing.The potential causes for leak could be due to steps utilized to de-air the device during guide preparation, loose connections between the luer and accessory devices (i.E.Stopcock, high pressure tubing or syringe) or not following the procedural steps outlined in the instructions for use (ifu).The discrepancy between what was reported (leak) vs what was observed (no leak) could be a result of user technique/procedural circumstances during device preparation.A review of the lot history record revealed no manufacturing nonconformities reported to this lot that would have resulted in this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.All available information was investigated and a conclusive cause for the reported leak could not be determined in this complaint.Based on the information reviewed, there is no indication of a product issue with respect to manufacture, design or labeling of the device.

• 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: 11631738
• MDR Text Key: 247383424
• Report Number: 2024168-2021-02881
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 01222U338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1