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

Model Number SGC0701

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Heart Failure/Congestive Heart Failure (4446)

Event Date 03/23/2023

Event Type  Injury  

Event Description

This is filed to report hypotension, hypoxia, heart failure and cardiac arrest, requiring intervention.It was reported that a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4+.After inserting the steerable guide catheter (sgc), the patient¿s blood pressure (bp) and oxygen saturation dropped.The patient went into cardiac arrest, requiring cardiopulmonary resuscitation (cpr).Thorough investigation for a pericardial effusion (pe) was repeatedly performed.There was no pericardial effusion ever found.There was a pleural effusion that was pre-existing prior to inserting any equipment into the patient, but that was never thought to be, or determined as the cause for the event.The patient had a left atrial-electrogram performed that showed no perforation of the left atrium.They also had a pulmonary arteriogram performed that ruled out a pe.The patient was eventually diagnosed with acute right heart failure and that is what was believe to have caused the event.They also think the patient may have vagaled causing the quick decrease in bp.There was no evidence that the sgc caused the patient effects.After the patient was stabilized, the procedure was continued with two clips implanted, reducing mr to grade 1.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 and without the device to analyze, the reported heart failure could not be determined.The cause of the reported hypotension and cardiac arrest appears to be cascading effects of the reported heart failure.The cause of the reported hypoxia cannot be determined.The reported hypotension, cardiac arrest, and heart failure are listed in the instructions for use (ifu) and are known possible complications associated with triclip procedures.The reported medical intervention was the results 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
• 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: 16742522
• MDR Text Key: 313317535
• Report Number: 2135147-2023-01645
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 21129R1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 86 KG