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

Catalog Number SGC0705

Device Problems Unstable (1667); Unintended Movement (3026)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that a patient presented with grade 4 functional mitral regurgitation (mr) for a mitraclip procedure.It was noted that femoral puncture was difficult and contrast imaging was performed.The steerable guide catheter (sgc) and clip delivery system (cds) were prepared and operated according to the instructions for use (ifu).Initial opening of the clip was attempted in the left atrium (la) and it could not open.Troubleshooting was carried out according to the ifu, but the conclusion was that it could not be opened.The clip was recovered and replaced with a new one.In addition, there were complaints that the sgc was not fastened with a fastener during the procedure and torque was taken in the anterior direction, so a replacement sgc was prepared, but the procedure was continued with the same sgc.When the clip was grasping the leaflets, the torque of the sgc was taken in the anterior direction.There were complaints that the fastener was loosely affixed, and the second physician continued the procedure while securing the sgc.The mr improved to grade 1+, and there was no health hazard to the patient.The physician made a comment to the developers at tokyovalves on (b)(6), "you will not improve the clip itself, so we will be in trouble if something like this happens." this was in reference to the clip being unable to open and the generation 5 prototype.The physician suggested an evolution of the clip as opposed to the cds for the new generation prototype.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

All available information was investigated and the reported unstable stabilizer fastener (sgc was not fastened with a fastener) and unintended movement of the sgc were confirmed via returned device 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 determined the reported unstable stabilizer fastener and unintended movement were due to the screw backing out from the handle adapter.The screw backing out appears to be due to the user over tightening the fastener and then applying high amounts of torque to the sgc while the fastener was tightened.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 18932651
• MDR Text Key: 338434793
• Report Number: 2135147-2024-01231
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648288654
• UDI-Public: (01)08717648288654(17)241030(10)31101R1018
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/22/2024

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: SGC0705
• Device Lot Number: 31101R1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2023
• 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: MITRACLIP (X2)
• Patient Age: 82 YR
• Patient Sex: Female