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

Catalog Number SGC0705

Device Problem Leak/Splash (1354)

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

Event Date 08/08/2022

Event Type  Injury  

Manufacturer Narrative

The device is expected to return for analysis, and has not yet been received.The investigation is not complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed due to a steerable guide catheter hemostasis valve leak, requiring intervention.It was reported that on (b)(6) 2022, a patient presented with grade 4 degenerative mitral regurgitation (mr) with a prolapsed posterior leaflet.The first xtw clip was deployed successful.After removal of the clip delivery system (cds), it was noted that the hemostasis valve of the steerable guide catheter (sgc) was not operating as intended.The hemostasis valve was not properly sealed, and blood was exiting freely.Air was observed in the sgc, but not the anatomy.Additional aspiration was required to assure air did not stay lodged in the sgc.A new sgc was used to complete the procedure.A second xtw clip was implanted, and the mr was reduced to 1-2.There was no adverse patient sequelae or a clinically significant delay.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported leak was unable to confirm via returned device 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.The investigation was unable to determine a cause for the reported leak.The reported unexpected medical intervention appears to be due to case specific circumstance.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: 15310873
• MDR Text Key: 298782480
• Report Number: 2135147-2022-00936
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: SGC0705
• Device Lot Number: 20401R156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2022
• 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
• Treatment: 1 MITRACLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention