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

Catalog Number SGC0705

Device Problems Break (1069); Difficult to Insert (1316)

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

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for 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.Based on available information, a cause of the reported difficult to insert (anatomy), associated with the resistance being encountered while inserting the sgc (steerable guide catheter) into the right femoral vein, could not be determined.The reported break (shaft), associated with broken sgc shaft, appears to be due to the reported difficult to insert (anatomy) as the sgc was being advanced against resistance.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4+.A steerable guide catheter (sgc) was inserted; however, resistance was noted when advancing the sgc into the right femoral vein.It was observed the sgc shaft was broken.Therefore, the sgc was removed and replaced.The procedure was continued with a new sgc, and one clip was successfully implanted, reducing mr to a grade of 1.There were no adverse patient effects and 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: 18753943
• MDR Text Key: 336285641
• Report Number: 2135147-2024-00804
• Device Sequence Number: 1
• Product Code: DRA
• 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
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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: 31003R1007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Male