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

Catalog Number SGC0702

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Unspecified Tissue Injury (4559)

Event Date 05/22/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This will be filed to report vascular damage.It was reported that a patient presented with grade 4 functional mitral regurgitation (mr), a restricted posterior leaflet, and vessel tortuosity.During a mitraclip procedure a steerable guide cather (sgc) was attempted to be advanced into the femoral vein.There was resistance felt and the sgc could not be advanced.The sgc was withdrawn and evaluated externally.Wrinkling and an accordion effect was observed on the distal shaft of the sgc.A replacement completed the procedure and one ntw was implanted at a2/p2.The mr was reduced to grade 1.One hour after the procedure, the patient became hemodynamically unstable (hypotension and rapid decrease in hemoglobin), and vascular damage was suspected.Vascular surgical intervention was required for retroperitoneal bleeding.The patient was discharged from the critical care unit.There were no adverse patient sequelae or clinically significant delay.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 complaints reported from this lot.Based on available information, a cause for the reported failure to advance could not be determined.The reported deformation due to compressive stress appears to be a cascading event of the failure to advance.The reported tissue injury, hemorrhage, hypotension, and anemia are cascading events of the failure to advance.Additionally, tissue injury, hemorrhage, hypotension, and anemia are listed in the ifu as known possible complications associated with mitraclip procedures.There is no indication of product issue with respect to manufacture, design or labeling.H6- 4559 was removed.

• 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: 17118992
• MDR Text Key: 317133036
• Report Number: 2135147-2023-02554
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2024
• Device Catalogue Number: SGC0702
• Device Lot Number: 30131R1111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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): Hospitalization; Required Intervention