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

Model Number SGC0701

Device Problems Break (1069); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Unintended Movement (3026)

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

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.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 suspected cable break.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with an mr grade of 4.The anatomy was tortuous.The steerable guiding catheter (sgc) failed to cross the septum, it would not pass the iliac due to resistance with the anatomy, and the shaft kinked.The sgc no longer steered when applying minus on the +/- knob.A cable break was suspected.The sgc was removed without issue.A new sgc was used.Two clips were implanted, reducing mr to 1.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.

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 complaint reported from this lot.All available information was investigated, and a conclusive cause for the reported failure to advance could not be determined in this complaint.The reported deformation due to compressive stress, unintended movement and break were cascading events that resulted from the troubleshooting steps/procedural circumstances.There is no indication of 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: 12003122
• MDR Text Key: 262960413
• Report Number: 2024168-2021-05008
• 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: 08/06/2021

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 Expiration Date: 02/24/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10225U146
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1