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

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 10/20/2022

Event Type  Injury  

Event Description

This is filed to report a leak requiring intervention.It was reported that the patient underwent a mitraclip procedure to treat mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) was advanced to the left atrium (la).After removing the dilator from the sgc it was noted that the sgc lost fluid column.Transesophageal echocardiogram (tee) confirmed that there was no contact of any tissue or posterior la wall.The sgc was brought down to the side of the patient and the air was aspirated.The sgc was placed back in the stabilizer however, it lost fluid column again.Additional troubleshooting was performed but with the same results.It was decided to remove the sgc and replace it.The procedure continued and the mr was reduced to a grade of 1.There were no adverse patient effects or clinically significant delay.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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 the reported complaint.Additionally, a review of the complaint history did not indicate a lot-specific product issue.All available information was investigated and without the device to analyze, a cause for the reported leak/splash associated with loss of fluid column after dilator removal cannot be determined.The 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: 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: 15773067
• MDR Text Key: 303542754
• Report Number: 2135147-2022-02023
• Device Sequence Number: 1
• Product Code: DRA
• 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,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2023
• Device Model Number: N/A
• Device Catalogue Number: SGC0701
• Device Lot Number: 20314R104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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