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

Model Number SGC0701

Device Problems Failure to Advance (2524); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.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 from the lot.All available information was investigated and based on the information provided the failure to advance the sgc resulting in unintended movement associated with the sgc slipping into the right atrium appears to be related to patient conditions and due to vessel tortuosity.There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report a steerable guide catheter that could not hold position within a chamber.It was reported that a patient presented with grade 4 functional mitral regurgitation (mr) and vessel tortuosity.During a mitraclip procedure, venous access was achieved from the left femoral vein, due to tortuosity on the right side.The steerable guide cather (sgc) was kinked/bent/scrunched while attempting to reach the inferior vena cava (ivc) (right before the bifurcation the device could not advance).It was noted that the femoral vein was very tortuous.There was a lot of resistance while advancing.The guide and sgc were removed and a kinked/bent tip was noted near the curve of the sgc.A new sgc was used and able to pass.The clip delivery system (cds) was advanced within the sgc, but was not implanted.The second sgc could not stay within the left atrium, as the same tortuosity prevented the sgc from holding position.The sgc was sliding back through the septum into the right atrium without manipulation.This motion was caused by resistance from vessel tortuosity.Therefore the procedure was discontinued without implanting a mitraclip.There were no adverse effects or clinically significant delay.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: 17050875
• MDR Text Key: 316934726
• Report Number: 2135147-2023-02427
• 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: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2024
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 30124R2118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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: MITRACLIP
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 76 KG