MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. KODEX EPD; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number KODEX EPD SYSTEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Heart Block (4444)

Event Date 11/22/2020

Event Type  Injury  

Event Description

It has been reported to philips that after an atrioventricular nodal re-entrant tachycardia ablation procedure, the patient developed atrioventricular block with intermittent left bundle branch block and had to be implanted a pacemaker.The patient was released from the hospital and is doing well.Philips has initiated an investigation of this complaint.

Event Description

Follow up: philips has investigated this complaint and confirmed that there was not malfunction of the epd kodex system.Patient was undergoing an atrioventricular nodal reentry tachycardia slow pathway ablation procedure with the anatomy and key electrical conduction system map guided by the epd kodex 3d system, fluoroscopy, and a standard electro physiology recording system.During the procedure the patient developed right bundle branch block.24 hours post procedure, the patient developed pr prolongation 300msec which 48 hours later developed to 2:1 atrioventricular block with intermittent left bundle branch block.A pacemaker was implanted to treat this condition.The analysis of the case files by philips shows frequent abrupt changes in the respiration profile as well as patient movements throughout the procedure.The ¿abrupt respiration¿ indicator was displayed by the epd kodex system alerting the physician of the respiratory drifts and movements.An additional alert was also given through fluoroscopy.These alerts were acknowledged by the physician who continued with the ablation procedure.The epd kodex system is designed to compensate respiratory drifts and gradual movements.Significant respiratory and motion shifts are alerted by the system through the ¿abrupt respiratory indicator¿.The instructions for use of the system include specific information on actions in the presence of abrupt respiration and patient movements.Kodex user manual doc lbl-00105 rev.3: section 5.3 instructs the user to ¿use common clinical practice for real-time verification of catheter locations and shape throughout the procedure (such as inspection of intracardiac signals, available imaging modalities, navigating the catheter back to a known previously mapped anatomical landmark, etc.) especially after patient movement (for example, due to cardioversion), in case of excessive sweating or inadvertent spillage of fluid in the vicinity of the dielectric sensors, while freezing during cryo-ablation or when encountering irregular deep breaths or sigh respiration or marked change in cardiac rate or rhythm.Failure to do so might result in incorrect display of the catheter location, and may lead to patient injury, such as cardiac perforation.Start a new map if necessary.¿.In this specific case the ablation was continued without creating a new map.Section 7.8.2 ¿ ¿in case of marked irregular breathing the operator should consider temporarily stopping imaging, mapping, and navigation.In rare occasions when the accuracy bar turns red for an extended period of time, consider pausing imaging.Since these instances usually have treatable physiological etiologies such as patient discomfort, sudden pain, and patient dozing off, once the problem is resolved and the patient has returned to normal and fairly regular respiration, the procedure can be resumed¿.In this specific case the accuracy bar turned red and in addition the respiration graph also indicated irregular respiration.Based on available information philips has concluded that the epd kodex system performed as intended.Indications were made to alert the physician of abrupt respiration changes and movement.The adverse event was procedure related where system indicator and instructions for use were not followed.

• Brand Name: KODEX EPD
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• MDR Report Key: 11044937
• MDR Text Key: 222622482
• Report Number: 3003768277-2020-01038
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00884838095229
• UDI-Public: 00884838095229
• Combination Product (y/n): N
• PMA/PMN Number: K180940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KODEX EPD SYSTEM
• Device Catalogue Number: 733015
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/26/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 62