MAUDE Adverse Event Report: ABBOTT MEDICAL G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Catalog Number SGC0702

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a leak, air embolism and cardiac arrest it was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.One clip was successfully deployed, reducing mr to a grade of 1-2.Therefore, the clip delivery system (cds) was removed from the steerable guide catheter (sgc) while aspirating without issues.However, while flushing the chambers, air was flushed through the guide, into the left ventricle (lv) and right coronary artery (rca).The physician stated the air came from the side port of the three-way stopcock.Most of the air aspirated, but the patient went into cardiac arrest and the chest compressions were performed.The patient is now in a stable condition.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported leak/splash could not be 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 identified no similar incidents reported from this lot.Based on available information and the returned device analysis, a cause of the reported leak/splash could not be determined as no issue was identified with returned device analysis.The reported air embolism appears to be related to the reported leak/splash.The reported cardiac arrest appears to be related to the reported air embolism.The reported patient effect of embolism and cardiac arrest, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical interventions were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• 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: 15794739
• MDR Text Key: 303639292
• Report Number: 2135147-2022-02055
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/29/2022

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: 05/31/2023
• Device Catalogue Number: SGC0702
• Device Lot Number: 20601R253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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