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

Catalog Number SGC0702

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

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

Event Date 01/27/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The clip delivery system referenced is filed under a separate medwatch report number.

Event Description

This is filed to report broken hemostasis valve and leak.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4.During preparation of a steerable guide catheter (sgc), the dilator was flushed; however, the hemostasis valve was spinning and would not stop indicating the hemostasis valve was broken and resulted in a permanent leak.Therefore, the sgc was not used in the patient and the procedure continued with a new sgc.Then a clip delivery system (cds) was advanced to the mitral valve; and the clip grasped both leaflets fine, but mr was not reduced.The clip was being re-positioned; however, one gripper arm was observed not fully lowering.The clip was then inverted and retracted back into the atrium to test the mobility of the grippers.Imaging confirmed that one gripper would not fully lower.The cds was then removed with the clip attached and the procedure was successfully completed with a new cds.One clip was implanted, reducing mr to 1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported leak and inability to close the valve were not confirmed via returned device analysis, as no issue was noted during testing.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 other complaints reported from this lot.The investigation determined the reported leak appears to be related to the inability to close the valve; however, a cause for the inability to close the valve cannot be determined.The discrepancy between what were reported and what was observed may have been due to the user technique during the prep versus the returned product analysis.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

N/a.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13544060
• MDR Text Key: 289291953
• Report Number: 2024168-2022-01620
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10908R136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• 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: STEERABLE GUIDE CATHETER