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

Model Number SGC0701

Device Problems Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)

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

Event Date 04/12/2023

Event Type  malfunction  

Manufacturer Narrative

All available information was investigated, and the reported deformation due to compressive stress (tip) was confirmed via device analysis visually.The reported deformation due to compressive stress (soft tip) was unable to be confirmed via device analysis.The reported difficult to insert (anatomy) 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 incidents reported from this lot.Based on available information, the reported/ observed deformation due to compressive stress (tip) was due to the inability to insert the sgc.The reported deformation due to compressive stress (soft tip) appears to be due to user perception, as no issue was found via device analysis.The reported difficult to insert (anatomy) associated with the inability to insert the sgc past the iliac vein was due to challenging patient anatomy (tortuous iliac vein).There is no indication of a product quality issue with respect to manufacture, design, or labeling.The additional mitraclip device referenced in b5 is filed under separate medwatch report number.Na.

Event Description

This is filed to report damage to the soft tip of the steerable guide catheter.It was reported that on 04nov2021, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr).Two clips were implanted with no reported issue.On (b)(6) 2023, the patient returned with worsening mr.The physician suspected that one of the implanted clips had loosened that caused the worsening mr; however, they were unable to detect it.Another procedure was performed to treat mr with a grade of 4.The patient presented with tortuosity in the iliac vein, and the steerable guide catheter (sgc) was not able to be advanced past it.The sgc was pulled, and a kink was observed on the tip of the sgc.Damage was noted on the soft tip.Another sgc was used to complete the procedure.One clip was implanted with no reported issue, reducing mr to grade 2.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• 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: 16875781
• MDR Text Key: 314637039
• Report Number: 2135147-2023-01967
• 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
• Report Date: 05/05/2023

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: 12/11/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 21208R2029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• 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
• Patient Age: 66 YR
• Patient Sex: Male