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

Catalog Number SGC0702

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 09/04/2023

Event Type  Injury  

Event Description

This is filed to report an atrial septal defect, requiring intervention.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) grade 4 with prolapsed anterior leaflet.Three clips were implanted with no reported issue.A fourth clip (xt) was advanced to the mitral valve.During grasping, it was noted that the posterior leaflet perforated.Mr was noted to increase due to the perforation.The clip was removed and a replacement xtw clip was implanted, reducing mr to grade 2.In the physician´s opinion, leaflet perforation was due to patient¿s anatomy and age.After removal of the steerable guide catheter (sgc), it was noted that the atrial septum was slightly torn causing shunting.The septum was closed with an atrial septal defect (asd) occluder.There was no clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the cause of the reported perforation was unable to be determined.The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.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.

• 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: 17818154
• MDR Text Key: 324266529
• Report Number: 2135147-2023-04180
• 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: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2024
• Device Catalogue Number: SGC0702
• Device Lot Number: 30531R1086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• 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
• Treatment: 3 IMPLANTED MITRACLIP
• Patient Outcome(s): Required Intervention