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

Model Number SGC0701

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/22/2021

Event Type  Injury  

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 are filed under separate medwatch report number.

Event Description

This is filed to report difficult to remove, delay, prolonged hospitalization, and surgical intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.A steerable guide catheter (sgc) was advanced to the mitral valve without issue.Then a clip delivery system (cds) was inserted in the sgc and advanced to the mitral valve.The clip grasped the leaflets fine; however, the clip would not completely close.It was noted that the arm positioner felt extremely tight and the clip would only close half way.Troubleshooting was performed and the clip appeared to be functioning properly.Therefore, the clip re-grasped the leaflets and the clip was locked sooner this time.However, the arm positioner felt tight again and the clip would not fully close.The clip was inverted and retracted back to the left atrium.The clip would still not fully close and so the clip was forced closed.The clip seemed closed, but when the clip was retracted back into the guide, the mandrel shaft separated and the clip became stuck at the tip of the guide.The soft tip of the sgc looked asymmetrical.Both the sgc and cds were being removed as a single unit, but the clip became stuck at the femoral groin causing a clinically significant delay.Tissue was observed in the clip.The physician stated that the tissue possibly came from the femoral vein.The patient remained hospitalized and a surgical cut-down was performed to remove the sgc and cds.The patient is stable and is pending another mitraclip procedure.No clips were implanted, and mr is 4.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported deformation of the soft tip was not confirmed; however, it was observed that the soft tip was torn.The reported difficult to remove the clip delivery system (cds) from the steerable guide catheter (sgc), and difficult to remove the device from the anatomy cannot be replicable in a testing environment.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 other complaints reported from this lot.The investigation determined the reported difficulty removing the cds from the sgc and difficulty removing from the anatomy were due to the procedural condition of the inability to close the clip.The observed torn soft tip was due to the clip getting caught on the guide (difficulty removing the cds from the sgc).The reported hospitalization, surgical intervention and delay to treatment/therapy were results of case-specific circumstances.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: 12294215
• MDR Text Key: 265764155
• Report Number: 2024168-2021-06950
• 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: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2022
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 10331R136
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention