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

Catalog Number SGC0702

Device Problems Break (1069); Positioning Failure (1158); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

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

Event Date 05/25/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report a potential cable break of the steerable guide catheter (sgc).It was reported that a patient presented with grade 3 secondary mitral regurgitation (mr) and severe vessel tortuosity.During a mitraclip procedure, a steerable guide catheter (sgc) could not advance further in the tortuous femoral vein.The sgc was removed and damage was noted below the tip.The curve was not able to be adjusted with the +/- knob.The sgc was not responsive to the knob, and it was unknown if a cable break occurred.A replacement sgc completed the procedure, and the mr was reduced to grade 1.There were no adverse patient effects or clinically significant delay.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the reported deformed sgc tip was confirmed via returned device analysis.The reported cable break, unable to curve, and unable to straighten were not confirmed via returned device analysis.The reported failure to advance n/a during procedure could not be replicated in a testing environment as it was related to patient anatomy or procedural 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 available information and the returned device analysis, the reported failure to advance was due to challenging patient anatomy.The reported deformed sgc tip was a cascading event of the reported failure to advance.The cause of the reported cable break, unable to curve, and unable to straighten were unable to be determined as they were not confirmed via returned device analysis.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 17136343
• MDR Text Key: 317246993
• Report Number: 2135147-2023-02596
• 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,Followup
• Report Date: 07/18/2023

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: 02/14/2024
• Device Catalogue Number: SGC0702
• Device Lot Number: 30215R1120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• 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