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

Catalog Number SGC0702

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 10/12/2022

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 being filed to report a steerable guide catheter (sgc) that was difficult to remove from the vasculature.It was reported that a patient presented with functional mitral regurgitation (mr), vessel tortuosity, iliac arteriovenous fistula (iavf), and obesity.During a mitraclip procedure, there was difficulty finding venous access with the sgc.The sgc could not advance through the iliac vein, and was stuck in the angulation of the vein.It was discovered there was a arteriovenous fistula, which was accidentally created by the operator during preparation of access by passing the transseptal needle through the arteries and vein.The sgc did not create the fistula.The sgc was able to be removed, but there was tissue damage to the artery departing from the iliac and a hemorrhage.The procedure was discontinued and the patient went into emergent surgery.Vein access was performed under ultrasonography (usg), and an arteriovenous shunt between the vein and some arteries (superficial, external, the artery which was departing from the iliac artery) was placed.The patient was transported to the intensive care unit and is currently in stable condition.No additional information was provided.

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 failure to advance and difficult to remove (anatomy) were due to patient condition.The reported patient effect of tissue injury and hemorrhage, as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.The reported surgical intervention was the result of case-specific circumstances.There is no indication of a product quality 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: 15735602
• MDR Text Key: 303083915
• Report Number: 2135147-2022-01929
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 12/15/2022

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: 08/01/2023
• Device Catalogue Number: SGC0702
• Device Lot Number: 20802R1115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 155 KG