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

Model Number SGC0701

Device Problem Difficult to Advance (2920)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/18/2023

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 identified no similar incidents reported from this lot.Based on available information, the cause of the reported difficult to advance associated with the difficult tsp crossing could not be determined.The cause of the reported thrombosis/thrombus (mitral/tricuspid valve: na) could not be determined.The reported patient effect of thrombosis/thrombus, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported medication required and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional mitraclip device referenced in b5 is being filed under a separate medwatch report number.

Event Description

This is filed to report thrombus.It was reported that a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with grade 4, anterior prolapse, and thickened leaflet.A steerable guide catheter (sgc) was used, but difficulties advancing to the septum occurred.The sgc was placed in the left atrium (la), and a mitraclip was introduced.As the clip was steered down toward the valve, a thrombus was noticed on the distal tip.The procedure was stopped to further evaluate.Imaging was performed through the valve and a growing thrombus of an unknown origin was observed.It was unable to be determined if the thrombus was on the clip or at the tip of the sgc.It was noted additional heparin was administered.The clip was brought back into the guide and removed from the patient.The thrombus remained at the guide catheter and appeared to be wrapped around the guide.An attempt to suction the thrombus with a non-abbott catheter was performed but was not successful.A non-abbott embolic protection filter was introduced, and the guide catheter was pulled back into the right atrium (ra) with thrombus intact completely in ra.Additional attempts to remove the thrombus with the non-abbott catheter were performed, but with no success.The guide catheter was removed and a larger non-abbott catheter was introduced into the ra to continue the extraction attempt.After multiple attempts, it was determined that the thrombus was adhered to the posterior wall of the ra and further attempts to remove the thrombus were abandoned.The patient was given a prophylactic dose of anticoagulants.The procedure was abandoned due to the patient required hematology evaluation for clotting defect and for further treatment options.The mr remained at grade 4.There was no clinically significant delay in the procedure.No additional information was provided.

• 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: 17099959
• MDR Text Key: 316950390
• Report Number: 2135147-2023-02502
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• 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
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2024
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 30117R1069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2023
• 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
• Treatment: CLIP DELIVERY SYSTEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 74 KG