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

Catalog Number SGC0702

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Positioning Failure (1158); Noise, Audible (3273)

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

Event Date 02/23/2023

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.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 cable break.It was reported this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4 and an enlarged atrium.The steerable guide catheter (sgc) was inserted and advanced into the left ventricle (lv).The clip delivery system (cds) was inserted, but an aortic hugger was observed.Therefore, plus-knob was applied to compensate for the hugger.After roughly a half turn of the plus knob, a snap was heard and the sgc would no longer move in the plus direction.The sgc and cds were removed and the sgc was replaced.Two clips were then 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

During return device analysis, the "+" cable was observed to be broken and was unable to be curved.Moreover, the reported noise could not be replicated in a testing environment as it was likely a symptom of the cable break.The reported difficult or delayed positioning (anatomy) could not be replicated in a testing environment as it was related to patient/procedural conditions 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 did not indicate a lot-specific quality issue.Based on available information and return device analysis, the reported difficult or delayed positioning (anatomy) associated with the aorta hugger appears to be due to procedural circumstances during device advancement.The cause of the reported cable break could not be determined.However, this cannot be confirmed.The cause of the reported snap noise and positioning failure (curve unable) appear to be cascading effects of the reported cable break.There is no indication of product 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: 16539507
• MDR Text Key: 311375249
• Report Number: 2135147-2023-01179
• 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: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2023
• Device Catalogue Number: SGC0702
• Device Lot Number: 21012R1017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• 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