MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS DISCOVERY IGS 730

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problems Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

Patient information not yet provided.Initial reporter address email not yet provided.Ge healthcare has initiated an investigation which is ongoing.A follow-up report will be submitted upon investigation closure.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2019 customer reported to ge application specialist that during an endovascular aneurysm repair (evar) procedure and after the image registration process, a nurse moved by mistake the joystick of the itu innova touch unit) located the table rails.It resulted in a displacement of the patient up by 2 cm while attempting to position the endovascular graft.As the patient movement remained unnoticed, which led to an acute 2cm erroneous deployment position of the endovascular graft.This required an unplanned conversion from a percutaneous approach into an open surgery to reposition the graft, restore normal renal perfusion and complete the abdominal aortic aneurysm (aaa) repair.The surgery was completed successfully and the patient did not have complications after the procedure.

Manufacturer Narrative

Block a1: no patient information have been provided.Block h6 : ge healthcare investigation about this event has been completed.On (b)(6) 2019 customer from (b)(6) hospital in uk, reported to ge application specialist that during an endo vascular aneurysm repair (evar) procedure, surgeon or a nurse moved the joystick of the itu located on the table rails by mistake.Due to this the image slightly moved from the pre identified location for deploying the stent and the vascular surgeon deployed the graft about 2cm above the renal without validating the registration.It blocked blood supply to the kidneys.The surgeon had to convert the procedure to an open surgery to reopen the renal to allow blood flow to the kidneys.The surgery was successful and the patient recovered after the surgery.It was concluded that the system may have contributed to the conversion of the minimal invasive procedure into open surgery, which is considered as a serious injury.Investigation results concluded that the root cause is a user error.Surgeon deployed the stent without reconfirming the location before the stent deployment.Operator manual have been reviewed and no usability concern has been identified.This issue remained isolated and neither design, assembly nor manufacture defect, nor failure or malfunction has been identified.After the incident, the customer has been reminded on the procedure by the ge application specialist and no further action is required at this time.

• Brand Name: DISCOVERY IGS 730
• Type of Device: DISCOVERY IGS 730
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• MDR Report Key: 9155071
• MDR Text Key: 167841264
• Report Number: 9611343-2019-00009
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K181403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention