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

Model Number SGC0701

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem Air Embolism (1697)

Event Date 06/14/2023

Event Type  Injury  

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 this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported improper or incorrect procedure or method was associated with accidently removing the stopcock when removing the cds.The reported leak/splash was a cascading event of the reported improper or incorrect procedure or method.The reported air embolism was a cascading event of the reported leak/splash.The reported patient effect of embolism, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.It should be noted that the mitraclip instructions for use (el2123903, revision c) states under section 24.4 to ¿confirm that the stopcock on the clip introducer flush port is closed and the clip introducer is de-aired.¿ since the user accidently removed the stopcock, this is considered as a deviation from the instructions for use (ifu).Furthermore, it was determined that the accidental removal of the stopcock contributed to the reported adverse events; therefore, a letter/in-service to address the deviation from ifu will be requested,.

Event Description

This is filed to report a device leak resulting in air embolism and intervention.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4+.A xtw (lot: 30327r1003) clip was attempted to be implanted but the valve gradient rose to 8mmhg, so it was removed.After the clip was removed, air was detected in the chamber of the steerable guide catheter (sgc).The tip of the sgc was against the back wall of the left atrium, creating a vacuum.The sgc was moved from the back wall and the air was aspirated out of the chamber.A second clip ntw (lot: 20628r163) and advanced into the sgc but then multiple air bubbles were noted in the left atrium.The patient was put in the trendelenburg position.The system was inspected and the stopcock on the sgc sideport was not present.It was accidently removed when removing the previous cds.The stopcock was put back on and then the air bubbles in the left atrium were aspirated successfully.No evidence of stroke or st elevation in the patient.The rest of the procedure was completed without incident.One clip was implanted, reducing mr to grade 2.No additional information was provided.

• Brand Name: G4 STEERABLE GUIDING CATHETER (CE)
• 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: 17240597
• MDR Text Key: 318342098
• Report Number: 2135147-2023-02882
• 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: 06/30/2023

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: 02/05/2024
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 30202R1035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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: 1 IMPLANTED MITRACLIP XTW; 1 MITRACLIP NTW
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic