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

Catalog Number SGC0702

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

Patient Problems Dyspnea (1816); Hemorrhage/Bleeding (1888); Pleural Effusion (2010)

Event Date 11/14/2023

Event Type  Injury  

Event Description

This report is being filed due to access site and plural bleeding, requiring treatment.(b)(6).Patient id: (b)(6).It was reported that on (b)(6) 2023, the patient presented with mitral regurgitation (mr) grade 3-4, an enlarged left atrium and anterior leaflet flail.One mitraclip was successfully implanted, reducing the mr to grade 1+.Post-procedure, access site bleeding was noted.A compression bandage was placed as treatment.On (b)(6) 2023, the patient had worsening dyspnea.Per imaging, a bloody sero-pneumothorax was noted with a shift of the central bronchial of the lower and med lungs.A pleural effusion was reported.As treatment a blood transfusion was provided.The event did not require additional hospitalization.Per physician, the sero-pneumothorax event was possibly related to the steerable guide catheter.There was no device malfunction associated with the device.No additional information was provided regarding this issue.

Manufacturer Narrative

A2, a4: patient demographics obtained from baseline data.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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.The investigation was unable to determine a cause for the reported pleural effusion and hemorrhage.The dyspnea appears to be a cascading effect of the pleural effusion.Pleural effusion, dyspnea, and hemorrhage are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported unexpected medical intervention was a result of case specific circumstance.There is no indication of a product 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: 18333917
• MDR Text Key: 330547401
• Report Number: 2135147-2023-05531
• 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,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SGC0702
• Device Lot Number: 30821R1082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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: 1 IMPLANTED MITRACLIP.
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 70 KG