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 Hypoxia (1918); Pericardial Effusion (3271)

Event Date 12/14/2023

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a mitraclip procedure was performed on (b)(6) 2023 to treat degenerative mitral regurgitation (mr) grade 3-4.The patient was multimorbid and in poor condition.The transseptal puncture was difficult due to pacemaker lead in right atrium, the steerable guide catheter (sgc) was advanced to the left atrium.While the guide wire was pulled back into the sgc under aspiration, blood pressure began to drop.There was no observed pericardial effusion.Cardio pulmonary resuscitation (cpr) was started and the sgc was pulled back into the right atrium.Hemoglobin dropped from 9 grams/decaliter (g/dl) to 7.2 g/l.Eventually, a pericardial effusion was observed.Pericardiocentesis was performed and 40 milliliters (ml) was drained.Cpr was continued for over 25 minutes without own blood pressure.Hemoglobin dropped to 4.6 dl.After 30 minutes of the cpr, the patient was pronounced dead.It was the physician's opinion that the steerable guide catheter did not cause the pericardial effusion, however it is unknown what the cause of the effusion is.It was thought to maybe be pre-existing due to the patient's poor condition.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 the available information the cause of the reported pe and death cannot be determined.The reported hypoxia appears to be a cascading effect of the reported pe.Additionally, the reported pe, death and hypoxia, are listed in instructions for use document, and are known possible complications associated with mitraclip procedures.The reported medical interventions were the result of case-specific circumstances.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: 18463794
• MDR Text Key: 332299095
• Report Number: 2135147-2024-00125
• 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,Followup
• Report Date: 02/06/2024

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 Catalogue Number: SGC0702
• Device Lot Number: 30609R3012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• 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 Outcome(s): Death
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 60 KG