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

Catalog Number SGC0702

Device Problem Failure to Advance (2524)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/08/2024

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 did not indicate a lot-specific quality issue.Based on available information, the reported failure to advance sgc (steerable guide catheter) across the septum appears to be related to challenging anatomy with rotated heart.A cause of the reported bleeding (femoral vein) could not be determined.The reported patient effect of hemorrhage, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected 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

It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with a grade of 3+, rotated heart, and enlarged left atrium.Trannseptal access was difficult due to the patient¿s rotated heart axis and very small membranous foramen ovale.After successful transseptal puncture, a steerable guide catheter (sgc) was inserted, but while advancing towards the left atrium (la), the sgc was tenting on the septum, and bleeding from the vena femoralis was observed.Therefore, advancing the sgc was stopped, and pressure was applied on the groin.After ten minutes, the bleeding was not stopping.Therefore, the sgc was retracted and removed from the patient.The bleeding of the femoral vein was treated with a z-suture, which stopped the bleeding.The procedure was discontinued with no clips implanted.The mr remained at a grade of 3+.It was noted that in the physician's opinion, it was not certain what the exact cause for the bleeding was, but the bleeding was potentially due to guide insertion, as the bleeding occurred shortly after.There was no clinically significant delay in the procedure.

• 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: 18565447
• MDR Text Key: 333503530
• Report Number: 2135147-2024-00327
• 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
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SGC0702
• Device Lot Number: 30810R1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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