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

Catalog Number SGC0705

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

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

Event Date 05/28/2021

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 difficult removal of the sgc.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.Patient had an enlarged atrium.The steerable guide catheter (sgc) was inserted, but during advancement, the sgc became stuck and was unable to advance further.The sgc was removed and a new sheath and guidewire were inserted.The sgc was then reinserted and was able to advance into the left atrium (la).However, while in the la, it was noted the sgc was difficult to advance and remove.The clip delivery system (cds) was in the la as well and it was noted the clip did not move while applying the a/p knob.The physician then decided to adjust the height of the lift.This allowed the clip to be correctly positioned.The clip was then successfully implanted, reducing mr to a grade of 2.Once the sgc was removed from the anatomy, it was observed to be kinked.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 for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported failure to advance.The reported kink on the steerable guide catheter (sgc) shaft appears to be due the failure to advance.The kink on the shaft resulted in the difficulty removing the device.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: 12033327
• MDR Text Key: 261990524
• Report Number: 2024168-2021-05198
• Device Sequence Number: 1
• Product Code: DRA
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2022
• Device Catalogue Number: SGC0705
• Device Lot Number: 10109U138
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM
• Patient Age: 82 YR
• Patient Weight: 40