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 03/19/2024

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 and prolapsed posterior leaflet.The steerable guide catheter (sgc) was prepared per the instructions for use (ifu) and was inserted without issues.However, after removing the dilator, a loss of fluid column occurred.It was noted that air was getting into the valve.Aspiration was performed, but the issue occurred again.Therefore, the sgc was removed and replaced.The procedure was completed with two clips implanted, reducing the mr to a grade of 2.There were no adverse patient effects and no clinically significant delay in the procedure.

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 the reported event.Additionally, a review of the complaint history identified no similar complaints from the lot.All available information was investigated and without the device to analyze, a cause for the reported leak/splash associated with loss of fluid column could not be determined.Unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• 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: 19066855
• MDR Text Key: 339672234
• Report Number: 2135147-2024-01599
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648288654
• UDI-Public: (01)08717648288654(17)241202(10)31204R1023
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 05/23/2024

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: 31204R1023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2023
• 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