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

Catalog Number SGC0702

Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

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

Event Date 04/04/2023

Event Type  malfunction  

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 did not indicate a lot-specific quality issue.Based on the available information the reported difficult to insert was due to challenging patient anatomy.Additionally, the reported deformation and tear at the soft tip appears be cascading effects of the reported difficult to insert.There is no indication of product issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the soft tip tearing.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 3.The patient presented challenging groin anatomy.The groin was dilated and the steerable guide catheter (sgc) was brought over the stiff wire in the femoral vein.Resistance was noted while advancing the sgc.The sgc was removed and inspected.The sgc soft tip was observed to be bent and torn.A replacement sgc was used to complete the procedure.The sgc soft tip was removed from the patient intact.There were no adverse patient effect and no clinically significant delay.No additional information was provided.

• 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: 16820282
• MDR Text Key: 314079223
• Report Number: 2135147-2023-01842
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2023
• Device Catalogue Number: SGC0702
• Device Lot Number: 21116R1108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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