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 Hemorrhage/Bleeding (1888); Pericardial Effusion (3271); Unspecified Tissue Injury (4559)

Event Date 08/11/2022

Event Type  Death  

Event Description

This is being filed to report an sgc that contributed to patient death.It was reported that on (b)(6) 2022, a patient presented with degenerative mitral regurgitation (mr), posterior prolapse, and posterior flail.The transseptal puncture was difficult, and a height of 4.0 cm was achieved after multiple attempts.While using the m knob to position the xtw mitraclip above the valve, the clip appeared to be caught on the left atrial appendage (laa) and mitral valve annulus junction.The device was able to be freed.Shortly after the device was freed, the patient blood pressure dropped rapidly and a pericardial effusion was noted.The patients pressure continued to drop.As treatment, pericardiocentesis was performed.The clip delivery system (cds) was removed and brought into the steerable guide catheter (sgc) and removed from the body.The sgc was retracted from the left atrium into the inferior vena cava (ivc).The scg was used to transfuse the blood that came from the pericardiocentesis.The patient continued to decompensate and required chest compressions, a surgeon was called.Chest compressions continued, but the hemorrhage could not be stopped.The patient's chest was opened, but resuscitation was unsuccessful and patient death occurred.In the surgeon's opinion, the effusion began at the base of the laa and the mitral valve annulus.The first hemorrhage occurred when the tip of the clip was stuck on the laa and mitral valve annulus.This caused a 2-3mm perforation in the laa.The sgc remaining in the ivc, while performing lengthy chest compressions, may have ruptured the ivc.No additional information was provided.

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The xtw mitraclip reported in event is filed under a separate medwatch report number.Na.

Manufacturer Narrative

A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the reported death is due to procedural conditions.The reported perforation of vessels is due to procedural conditions.Additionally, thrombus is listed in the ifu as a known possible complication associated with mitraclip procedures.The reported hemorrhage is a cascading event of the perforation of vessels.Additionally, death, perforation of vessels, and hemorrhage are listed in the ifu as known possible complications associated with mitraclip procedures.There is no indication of a product 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: 15350970
• MDR Text Key: 299197186
• Report Number: 2135147-2022-00996
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2023
• Device Model Number: SGC0701
• Device Catalogue Number: SGC0701
• Device Lot Number: 20222R453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Male