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

Catalog Number SGC0705

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914)

Event Date 12/04/2023

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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.The investigation was unable to determine a cause for the reported leak.The reported air embolism and subsequent hypotension appears to be related to the reported leak.Air embolism and hypotension are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported medication required was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

It was reported that a mitraclip procedure was performed to treat a degenerative mitral regurgitation (mr) with grade of 4.After inserting the steerable guide catheter (sgc) into the left atrium, the dilator wire was removed according to the instruction for use (ifu).Although we confirmed that there was reverse blood by suctioning the syringe and that there was no air in the sgc column, the blood pressure decreased after the dilator was removed.Transesophageal echocardiogram (tee) revealed abnormal left ventricular wall motion, and vasopressors were administered.Hemodynamics improved after about 5 minutes.A thorough examination of the coronary artery using a contrast agent revealed no stenosis.It was suspected that this was a temporary coronary embolization due to air entering the anatomy due to the sgc; however, air could not be confirmed under echocardiogram or visually in the sgc.The procedure was then continued with one clip implanted, reducing mr to grade 1.There was no clinically significant delay in the procedure.No additional information provided.

• 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: 18400983
• MDR Text Key: 331424988
• Report Number: 2135147-2023-05713
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGC0705
• Device Lot Number: 30816R1029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 48 KG