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

Catalog Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

All available information was investigated and the reported leak was not 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 did not indicate a lot-specific quality issue.The investigation was unable to determine a cause for the reported leak.The reported air embolism and subsequent ekg/ecg changes appears to be related to the reported leak.Air embolism and ekg/ecg changes are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported unexpected medical intervention was a result of case specific circumstance.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

This is filed to report a leak and air embolism.It was reported that a patient presented with grade 4 functional mitral regurgitation (mr) and a restricted posterior leaflet for a mitraclip procedure.During clip insertion it was noted that there was air in the end of the steerable guide catheter (sgc) on the echocardiogram.The clip introducer was removed from the sgc and the sgc was aspirated.It was noted that there was air coming back into the hemostasis valve of the sgc.The sgc required additional aspiration.Air had entered into the anatomy and there were st changes, which resolved on it's own without intervention.It was decided at that time to remove the sgc and replace it with another.There were no adverse patient effects or clinically significant delay.No additional information was 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: 17886122
• MDR Text Key: 325087991
• Report Number: 2135147-2023-04364
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• 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: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SGC0701
• Device Lot Number: 30606R1099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 60 KG