MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR); CATHETER, STEERABLE

Catalog Number SGC0701

Device Problems Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)

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

Event Date 10/06/2023

Event Type  malfunction  

Event Description

It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 4, thick leaflets, and some focal calcification.One clip was successfully implanted, reducing mr to a grade of 3.To further reduce mr, an xtw clip was inserted, but while positioning in the left atrium (la), the posterior gripper would not lower.Therefore, the decision was made to not use the clip.However, while attempting to remove the clip, it became caught on the tip of the steerable guide catheter (sgc).Troubleshooting was performed, but the devices were unable to be separated.Therefore, both devices were retracted together.When retracting from the right atrium (ra) into the femoral vein, the clip detached from the mandrel.It was noted the clip remained attached to the lock line.Minor surgery was needed to remove the mitraclip devices.The procedure was discontinued, and mr was reduced to a grade of 3.The steerable guide catheter (sgc) was examined after removal of the device and damage was noted on the soft tip.An indent at the tip of the guide where the clip had been stuck was noticed.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report.

Manufacturer Narrative

H6: device code 2017 - failure to follow steps / instructions the reported instruction for use (ifu) deviation could not replicated in a testing environment as it was related to patient/procedural conditions or operational circumstances.Additionally, it was observed that the steerable guide catheter (sgc) soft tip was deformed, braided shaft & hemostasis valve were torn.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.Based on available information and returned device analysis, the cause of the reported ifu deviation was due to the user not straightening the guide prior to retraction.The deformed soft tip appears to be due to a combination of the reported ifu deviation and procedural conditions.The observed torn braided shaft & hemostasis valve were due to procedural conditions.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

• Brand Name: MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)
• 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: 18030657
• MDR Text Key: 326863289
• Report Number: 2135147-2023-04768
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 01/17/2024

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 Catalogue Number: SGC0701
• Device Lot Number: 30627R1079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• 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: CLIP DELIVERY SYSTEM.; IMPLANTED MITRACLIP.
• Patient Age: 82 YR
• Patient Sex: Male