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

Model Number SGC0701

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

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 and return device analysis, the cause of reported leak during procedure cannot be determined.The cause of the observed break appears to be due to user technique (excessive force).The cause of the observed bent on the sgc cannot be determined.The reported 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.

Event Description

This is filed to report a leak of the sgc.It was reported that a patient presented with grade 4 mitral regurgitation (mr), posterior leaflet flail, and a prolapsed posterior leaflet.During a mitraclip procedure, as the dilator and the guide wire were removed from the steerable guide catheter (sgc), air was noted.Aspiration was performed to remove the air from the device.Additionally, the stopcock was tightened on the hemostasis valve, and the flush port broke off.The sgc, dilator, and guide wire were removed together.Air did not enter the anatomy.A replacement completed the procedure.The mr was reduced to grade 2 with one mitraclip implanted.There were no adverse patient effects or clinically significant delay.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: 17050661
• MDR Text Key: 316464893
• Report Number: 2135147-2023-02425
• 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: 06/02/2023

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: 12/08/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 21209R1067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2022
• 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
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 95 KG