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

Catalog Number SGC0702

Device Problems Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

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

Event Date 08/18/2023

Event Type  malfunction  

Event Description

This is filed to report tear in the hemostasis valve and deformation of the shaft.It was reported that a mitraclip procedure was performed to treat a functional mitral regurgitation (mr) with grade of 3-4.An xtw clip was advanced to the mitral valve and a grasp of the leaflets was achieved.Leaflet insertion was reported to be good and stable.Mr was reduced to grade 1.Both establishing final arm angle (efaa) tests were performed with no issue.Deployment steps was performed per instruction for use (ifu).After deployment, echocardiography showed that the clip had opened to about 40° degrees.Mr increased to grade 2-3.The clip is stable on the leaflets.It was decided against a second clip for the time being.The steerable guide catheter was returned to abbott and the devices analysis revealed that the hemostasis valve was torn, and the shaft was deformed.It was stated by the physician that defect was not noted during the procedure.There was no clinically significant delay in the procedure and no adverse patient sequelae.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and it was observed that the sgc shaft was kinked, and the hemostasis valve was torn.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 observed deformation due to compressive stress (shaft) associated with the sgc shaft kink, and the observed material split, cut or torn associated with the observed torn hemostasis valve, appear to be due to post-procedural shipping/ handling, as the sgc was returned unseated in a red biobag with the cds inserted, and no issues were noted with the sgc during the procedure.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.

• 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: 17729154
• MDR Text Key: 323179563
• Report Number: 2135147-2023-03955
• 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
• Report Date: 09/12/2023

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: 05/07/2024
• Device Catalogue Number: SGC0702
• Device Lot Number: 30509R2095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2023
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 80 KG