MAUDE Adverse Event Report: ABBOTT MEDICAL G4 STEERABLE GUIDING CATHETER (CE); 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 04/03/2023

Event Type  malfunction  

Manufacturer Narrative

In this case, the return device analysis confirmed the reported deformation due to compressive stress and additionally the braided shaft was observed to be torn.However, the reported difficult to insert (anatomy) during procedure could not be replicated in a testing environment due to could be related to patient-anatomy/procedural or operational circumstances.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 the available information and the return device analysis, the cause of the reported difficult to insert (anatomy) was due to challenging patient anatomy.Additionally, the reported deformation and tear observed on the device are 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 torn material.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) with grade 4+ and a tortuous vessel in the vena cava.While inserting a steerable guide catheter into the groin resistance was encountered.Fluoroscopy revealed that the guide did not advance further into the vena cava inferior.The vessel was dilated with several non-abbott dilators.The sgc was inserted into the left groin, but the same issue occurred.There was no possible access for the sgc and so the procedure was aborted.After the sgc was removed from the patient, heavy kinking to the guide tip was observed.There was no clinically significant delay in the procedure and no adverse patient effects.The returned device analysis revealed the braided shaft was observed to be torn.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: 16969189
• MDR Text Key: 316333054
• Report Number: 2135147-2023-02226
• 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: 05/19/2023

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: 01/08/2024
• Device Catalogue Number: SGC0702
• Device Lot Number: 30106R1076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• 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