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

Catalog Number SGC0702

Device Problem Leak/Splash (1354)

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

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report leak and medical intervention it was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.It was noted enlarged atrium.A steerable guide catheter (sgc) was advanced into the left atrium without issue.Then the clip introducer of the clip delivery system (cds) was inserted into the hemostasis valve of the sgc.When the clip was approximately 5cm inserted into the sgc, the hemostasis valve appeared to have filled with air.The air was retracted, but the lumen filled itself with air again.Therefore, the clip was retracted into the clip introducer and removed from the sgc.Two total aspirations were performed and air did not enter the patient.The sgc was removed and the procedure was successfully completed with a new sgc and the same 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

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of the complaint history identified no other complaints reported from this lot.Based on available information, a cause for the reported loss of fluid column during the procedure could not be determined.The reported aspirations were the results 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 VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12435992
• MDR Text Key: 270327034
• Report Number: 2024168-2021-07925
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

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: 02/22/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10223U352
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 10/04/2021
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention