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

Catalog Number SGC0702

Device Problem Difficult to Insert (1316)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); Cardiogenic Shock (2262)

Event Date 03/22/2023

Event Type  Death  

Manufacturer Narrative

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

Event Description

This is filed to report a perforation, bleeding, cardiac arrest and death.It was reported that a mitraclip procedure was performed to treat functional mitral regurgitation (mr).The patient was hypotensive at the start of the procedure and this led to arrhythmias.This was resolved by cardiopulmonary resuscitation (cpr) immediately after the intubation of the patient.After a successful transseptal puncture, the femoral vein was pre-dilated before the steerable guide catheter (sgc) insertion because of fibrotic tissue at the groin site due to patient's pre-existing peripheral arterial disease.The sgc was inserted into the femoral vein about 10 to 15cm before encountering blockage/resistance.The physician looked at fluoro with contrast and noticed a perforation in the femoral vein.Two stents were placed to try and stop the bleeding but were unsuccessful.A vascular surgeon was called in and two stentgrafts were placed which stopped the bleeding.However, during the bleeding the patient remained hypotensive which led to several cardiac arrests each time requiring cpr.After performing about 45 minutes of cpr the patient went into cardiogenic shock which led to the death of the patient.The physician is unsure what caused the perforation, but it is thought the sgc worsened the perforation.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.Additionally, a review of the complaint history identified no other complaints reported from this lot.Based on all available information, the reported difficult sgc insertion appears to be due to challenging patient anatomy.The reported vein perforation, hemorrhage, cardiac arrest, cardiogenic shock, and death appear to be cascading events of the difficult sgc insertion.Additionally, vessel perforation, cardiac arrest, hemorrhage, and cardiogenic shock are listed in the instructions for use (ifu) as known potential complications associated with mitraclip procedures.The reported unexpected medical interventions (cpr, stent placements) are the results of case-specific circumstances.There is no indication of product issue with respect to manufacture, design or labeling.In addition, the event was reviewed by an abbott senior director of medical affairs.The reviewer stated, ¿the femoral vein injury was the result of femoral vein access with manipulation of wires, catheters and the steerable guide catheter.This patient appeared to be a high-risk patient that had arrythmia issues and required cpr from general intubation.It is unsure when this femoral vein tear occurred but became relevant as the steerable guide was being introduced into the femoral vein.The cascade of events which led to the patient¿s death seemed to start at the time of intubation and anesthesia induction and were exacerbated by femoral vein rupture and associated significant bleeding.The femoral vein injury was likely due to the insertion of the sgc into a groin with challenging anatomy (fibrosis as documented).While efforts to repair the perforation were successful but the patient¿s condition had declined significantly throughout this time and progressed into cardiogenic shock and eventually ending with the patient expiring.¿.

• 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: 16752341
• MDR Text Key: 313419837
• Report Number: 2135147-2023-01676
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2023
• Device Catalogue Number: SGC0702
• Device Lot Number: 21219R1116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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): Death