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

Model Number SGC0701

Device Problems Leak/Splash (1354); Difficult to Advance (2920); Unintended Movement (3026)

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

Event Date 03/13/2023

Event Type  malfunction  

Event Description

This is filed to report unintended movement and a leak it was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.It was noted there was vessel tortuosity, the inferior vena cava (ivc) was at a weird angle, the septum was elastic and thick, and the patient had scoliosis.The patient's right groin was also highly bruised from a previous procedure so they tried to avoid it by achieving access through the left groin.The steerable guide catheter (sgc) was inserted using the left groin, but was unable to cross the septum.It was noted the angle at which the septum was approached was difficult.The sgc was removed, and a balloon was inserted to help the sgc cross.This occurred multiple times.It was noted that due to multiple insertions of the sgc, the device was flushed multiple times.The sgc eventually able to cross the septum; therefore, the clip delivery system (cds) was inserted and advanced into the left atrium (la).However, the sgc started slipping back into the right atrium (ra).This occurred multiple times.The physician decided to remove the devices and attempt access through the right femoral vein.Prior to inserting the sgc, the physician observed a bubble in the back of the column.Therefore, the sgc was replaced.One clip was then successfully implanted, reducing mr to a grade of <1.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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 reported difficult to advance associated with the difficult transseptal access was due to challenging anatomy in conjunction with procedural conditions.The reported unintended movement appears to be due to insertion through left groin and the tortuous nature of vessel which resulted in unintended curves/ tension on the system.A cause of the reported leak/ splash could not be determined.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: 16669371
• MDR Text Key: 312714350
• Report Number: 2135147-2023-01458
• 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,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 21108R1030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• 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
• Treatment: CLIP DELIVERY SYSTEM.
• Patient Age: 89 YR
• Patient Sex: Female