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

Model Number SGC0701

Device Problem Difficult to Remove (1528)

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

Event Date 07/15/2021

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.The additional device referenced is filed under a separate medwatch report number.

Event Description

This is filed to report difficult to remove the cds from the sgc.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with grade of 4.The clip delivery system (cds) was advanced to the mitral valve and grasping was performed but grasping was difficult due to pre-existing tethered leaflets.It was decided to remove the cds, the clip was locked and during removal, when the clip was in the hemostatic valve of the sgc, the physician pulled hard on the device which caused the clip to open up.The clip became stuck in the hemostatic valve and it was noted that the arm positioner was not moving and the clip could not be closed.Troubleshooting was performed but was unsuccessful; therefore, it was decided to release (deploy) the clip inside the hemostatic valve.Then, the cds was removed without issue and the sgc was removed with the deployed clip inside the hemostatic valve.A new sgc was used and two clips were implanted reducing mr to 1.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported difficult to remove could not replicate as the clip was deployed in the steerable guide catheter (sgc) hemostasis valve.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 lot specific product issue.All available information was investigated and the reported difficult to remove appears to be due to user technique/procedural circumstance.The observed material split/cut appears to be a cascading effect of the troubleshooting steps and is due to procedural circumstance.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: 12267212
• MDR Text Key: 264744920
• Report Number: 2024168-2021-06746
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2021
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 01026U124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Age: 60 YR