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

Model Number SGC0701

Device Problems Break (1069); Positioning Failure (1158); Mechanical Jam (2983)

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

Event Date 10/21/2022

Event Type  malfunction  

Event Description

This is filed to report a cable break and unable to straighten.It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3-4.The steerable guide catheter (sgc) was prepared per the instructions for use (ifu) and was inserted into the anatomy.However, it was observed the +/- knob was not turning and a cable break was suspected as the device was unable to curve or straighten.Therefore, the sgc was removed and replaced.The clip delivery system (cds) was inserted, but the leaflets were unable to be grasped as the physician felt the grippers were not lowering.The clip was removed and tested outside the anatomy.The clip arms were opened to 140 degrees, but the grippers only dropped to 120 degrees.No additional clips were attempted, and the procedure was discontinued.Mr remained at a grade of 3-4.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device has been received.However, investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip referenced is being filed under a separate medwatch report number.

Manufacturer Narrative

All available information was investigated and the reported unable to curve, unable to straighten, cable break, and knob jam were not confirmed via returned device 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 other complaints reported from this lot.The investigation was unable to determine a cause for the reported mechanical jam of the knob.The inability to curve and inability to straighten appear to be related to the reported knob jam as no issue was noted during device testing and during prep.The reported broken cable was due to the user speculation.There is no indication of a product 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: 15762268
• MDR Text Key: 307310790
• Report Number: 2135147-2022-02009
• Device Sequence Number: 1
• Product Code: DRA
• 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: 12/19/2022

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: 04/21/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20421R126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2022
• 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
• Patient Sex: Female