MAUDE Adverse Event Report: ABBOTT MEDICAL G4 STEERABLE GUIDING CATHETER (CE); CATHETER, STEERABLE

Catalog Number SGC0702

Device Problems Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 4 and pressure gradient of 2.A mitraclip xtw was successfully implanted, reducing mr to a grade of 2.To further reduce mr, another xtw was inserted, and grasping was performed.However, the gradient increased to 8mmhg, causing the blood pressure to decrease.Due to the increased gradient, the clip was retracted back into the left atrium (la).It was noted that the gradient returned to baseline and the blood pressure normalized.It was then observed that the clip would not open past 10 degrees.Troubleshooting was performed, but the issue was unable to be resolved.It was then observed the clip was unable to close and remained opened at 10 degrees.The clip delivery system (cds) and steerable guide catheter (sgc) were removed together.It was noted the clip was not able to retract into the sgc but caused damage to the septum during removal.The mr remained at a grade of 2; therefore, the physician decided to discontinue the procedure.There was no clinically significant delay in the procedure.Subsequent to the previously filed report, the mitraclip xtw and steerable guide catheter returned for analysis.Visual inspection of the sgc soft tip was observed to be damaged.Additionally, visual inspection of the hemostasis valve is torn, with the clip introducer inside.

Manufacturer Narrative

In this case, the returned device analysis confirmed the deformation due to compressive stress associated with a deformed steerable guide catheter (sgc) soft tip and material split, cut or torn as the soft tip was observed to be deformed and was also noted to be torn and the silicone valve inside the hemostasis valve was observed to be torn.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated and the deformed and torn soft tip and torn silicone valve of the hemostasis valve appear to be related to procedural conditions associated with the clip unable to close fully and the way the devices were removed together from the patient and shipped.There is no indication of a product issue with respect to manufacture, design or labeling.The additional cds0702-xtw device referenced in b5 is filed under separate medwatch report number (b)(6).

• Brand Name: G4 STEERABLE GUIDING CATHETER (CE)
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18970551
• MDR Text Key: 338508109
• Report Number: 2135147-2024-01329
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231032
• UDI-Public: (01)08717648231032(17)240212(10)30213R2002
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2024
• Device Catalogue Number: SGC0702
• Device Lot Number: 30213R2002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; CLIP DELIVERY SYSTEM