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

Catalog Number SGC0701

Device Problem Leak/Splash (1354)

Patient Problem Air Embolism (1697)

Event Date 09/14/2023

Event Type  Injury  

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 anterior leaflet for a mitraclip procedure.A steerable guide catheter (sgc) was placed in the left atrium (la) without issue.After removing the dilator and guidewire, there was a sudden influx of air into the la.The sgc tip was not affixed to any structures when the guidewire and dilator were removed while aspirating.The 3-way stopcocks were closed and working properly.The sgc was immediately retracted into the right atrium (ra) and subsequently removed from the anatomy.Air bubbles that became trapped in the ascending aorta were removed by gaining arterial access with a multi-purpose guide to manually aspirate the bubbles.A replacement sgc was prepared and functioned without issue.The first clip was placed on anterior leaflet 2 and posterior leaflet 2 (a2/p2).There was residual mr lateral to the first clip.A second clip (xtw-30621r1107) was placed lateral to the first clip.Two grasping attempts were made.Despite a solid grasp, there was remaining mr lateral to the clip.The gradient was also 6-7mmhg.The second clip was removed and replaced (xtw for an ntw).The gradient returned to baseline and per the physician it was not clinically significant.As the replacement clip was being aligned, it was observed that the lateral a2 had a tear in the middle of the leaflet.No grasp was attempted and it was removed from the anatomy.It is believed that the second clip (xtw-30621r1107) contributed to the tear of a2.The final mr was grade 2-3.After the procedure, the patient was awoken in the room and did not show signs of cognitive/neurological damage associated to the air leak.There were no adverse patient sequelae or clinically significant delay.No additional information was provided.

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 appears to be related to the reported leak.Air embolism is listed in the instructions for use as a known possible complication 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.

• 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: 17894822
• MDR Text Key: 325244641
• Report Number: 2135147-2023-04386
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/09/2023

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 Expiration Date: 04/25/2024
• Device Catalogue Number: SGC0701
• Device Lot Number: 30426R1109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• 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; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 54 KG