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 Type  Injury  

Event Description

It was reported that a patient presented with grade 4 degenerative mitral regurgitation (mr) for a mitraclip procedure.The steerable guide catheter (sgc) was placed across the septum with no issues.Once across, there was significant bubbles in the left atrium la, as if the drips were too high.Drips were turned down, but there was still a lot of bubbles, enough that it was difficult to see the anatomy.The sgc was holding column, but the physician thought it might be leaking somehow.The sgc was aspirated while the tip was still in the la, and it lost column.The device had held column on the proximal end, until it was aspirated.Then on aspiration, the column was lost for a few seconds, then regained.Bubbles were still present, so the tip of the sgc was pulled into the right atrium (ra).The bubbles were now mostly gone from the la, so the sgc was exchanged for a new one.Additional aspiration was required as the device was removed.The new sgc had no problems and the case proceeded normally.The first sgc was tested on the back table and held column well.It was left on the back table filled with saline for about 30 minutes and did not leak.Per the physician, the bubbles resolved on their own and there was a discussion that the "bubbles" may not have been air and was turbulence flow.The mr was reduced to grade <1 with one clip implanted.There were no adverse patient sequelae or clinically significant delay.The next day that the patient had no issues clinically, and the echocardiogram was good.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified 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 reported from this 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.Image resolution poor was related to procedural circumstances as difficult visualization was reported due to the excessive bubbles.A cause for the reported air embolism cannot be determined.Air embolism is listed in the instructions for use (ifu) as a known possible complication associated with mitraclip procedures.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: 18570482
• MDR Text Key: 333560158
• Report Number: 2135147-2024-00339
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• 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: 30928R2045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• 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: 93 YR
• Patient Sex: Female