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

Model Number SGC0701

Device Problems Material Frayed (1262); Difficult to Insert (1316); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

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

Event Date 04/26/2023

Event Type  malfunction  

Event Description

This will be filed to report a torn shaft and frayed tip of a steerable guide catheter (sgc).It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr) grade 4 with vessel tortuosity.It was noted that the sgc was difficult to insert due to the patient's anatomy.The physician attempted to dilate the vein, switch the size of the dilator and switch the guidewire.The sgc still could not be advanced and subsequently a tear occurred and the tip ring frayed in the attempts to advance.The devices were removed and the left groin was accessed with a new sgc.1 mitraclip was implanted and the procedure was concluded with a resulting mr grade of <1.There was no clinically significant delay in the procedure and no adverse patient sequelae.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.

Event Description

N/a.

Manufacturer Narrative

All available information was investigated, and the reported deformation (tip), material torn (shaft), and material frayed was confirmed via returned device analysis.The reported difficult to insert and failure to advance could not be replicated in a testing environment.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, the reported deformation (tip) was due to the difficult steerable guide catheter (sgc) insertion as inserting the sgc against resistance would likely result in shaft deformation.The reported difficult to insert and failure to advance associated with failed sgc insertion were due to challenging anatomy with tortuous vein.The reported material torn and material frayed on the sgc shaft were also due to the attempts to insert the sgc against resistance.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: 16955897
• MDR Text Key: 315537286
• Report Number: 2135147-2023-02197
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• 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: 06/15/2023

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: 01/04/2024
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 30105R1074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 75 KG