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

Catalog Number SGC0701

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 02/02/2024

Event Type  Injury  

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.Based on available information, the reported image resolution poor was associated with difficult imaging.The cause of the reported perforation, associated with the atrial septal defect (asd) occurred after sgc (steerable guide catheter) removal, could not be determined.The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.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 degenerative mitral regurgitation (mr) with a grade of 4+, a rotated heart, and restricted bi-leaflets.It was noted imaging was challenging throughout the procedure.A steerable guide catheter (sgc) (31005r1009) and an xtw clip (31019r1057) were inserted.However, due to a high transseptal puncture the trajectory was not satisfactory, and the clip was unable to advance.Therefore, the clip was removed and replaced.The physician decided to remove and re-prepare the sgc.The sgc and a new xtw clip (31031a1030) were inserted.However, the clip was unable to advance due to the high transseptal puncture and an aorta hugger.Therefore, the clip was removed.However, after removal of the sgc, an atrial septal defect (asd) occurred.For treatment, a closure device was implanted.The procedure was discontinued, and mr remained at a grade of 4+.There was 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: 18778550
• MDR Text Key: 336222138
• Report Number: 2135147-2024-00861
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SGC0701
• Device Lot Number: 31005R1009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2023
• 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 (X2)
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Sex: Male