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

Catalog Number SGC0705

Device Problem Leak/Splash (1354)

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

Event Date 03/27/2024

Event Type  malfunction  

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.

Event Description

It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4, a flail, and a prolapsed posterior.An xtw clip was inserted and both leaflets were able to be grasped.However, while removing the lock line (ll), it got stuck.Troubleshooting was performed, but the ll was still unable to be removed.The physician decided to use a snare as a precaution when removing the clip.The clip was unable to pass through the tip of the steerable guide catheter (sgc).Therefore, the clip was brought to the femoral region and a surgical procedure was performed to removed the clip.The sgc was prepped again to be inserted on the left side of the patient.Upon inserting the dilator during preparation, a loss of fluid column occurred.Therefore, the sgc was replaced.Two clips were then implanted, reducing mr to a grade of 2.There were no clinically significant delay in the procedure.

• 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: 19144819
• MDR Text Key: 341125341
• Report Number: 2135147-2024-01771
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648288654
• UDI-Public: (01)08717648288654(17)240708(10)30710R1093
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/19/2024

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: 30710R1093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2023
• 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: IMPLANTED MITRACLIP
• Patient Age: 93 YR
• Patient Sex: Male