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

Catalog Number SGC0702

Device Problem Leak/Splash (1354)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Returned device analysis confirmed the reported leak.Additionally, the silicone valve inside the sgc hemostasis valve was observed to be torn.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints reported from this lot.All available information was investigated, and the reported leak appears to be related to the observed tear in the silicone valve of the sgc hemostasis valve; however, how the silicone valve got torn cannot be determined.Additionally, a cause for the reported thrombus cannot be determined.Thrombus is a known possible complication associated with mitraclip procedures.Unexpected medical intervention and medication required were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4.A steerable guide catheter (sgc) was inserted without issues.However, after removing the dilator, a thrombus was observed in the left atrium (la).To treat the thrombus, aspiration was performed, and the thrombus was pulled back into the sgc.A transesophageal echocardiogram (tee) confirmed that the thrombus was in the sgc.Heparin was administered to treat the thrombus.The sgc was removed from the patient and was rinsed and prepared.However, while pushing the dilator forward, the sgc drew air.The leak was observed on the hemostatic valve on the sgc.Aspiration was performed to remove the air.Therefore, the sgc was not used and replaced.The procedure was completed with three clips implanted, reducing the mr to trace.There were no adverse patient effects and 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: 19012191
• MDR Text Key: 339023381
• Report Number: 2135147-2024-01406
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231032
• UDI-Public: (01)08717648231032(17)241205(10)31207R1095
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2024

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 Catalogue Number: SGC0702
• Device Lot Number: 31207R1095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2023
• 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