MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE); COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number D-1286-03-S

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762)

Event Date 02/12/2015

Event Type  Injury  

Event Description

It was reported that a patient, (b)(6) year old, male, underwent an atrial flutter (afl) procedure with a c3 interface therapeutic cable and received an electrical shock, became asystolic and then went into atrial fibrillation which required hemodynamic support.An ablation catheter that was already in the patient¿s heart was plugged into a reprocessed mapping cable which was already connected to the patient interface unit (piu).Upon connection, there were large amplitude spikes at about 100 ms and signal saturation was noticed throughout all electrocardiograms (ecg), electrograms (egm) and monitoring channels making it unable to see any ecg signal.In addition, there was a "current leakage" alert on the carto 3 system.The patient, who was moderately sedated, received an electric shock for six seconds when the catheter was connected to the cable.It was then noted that the patient became asystolic for approximately three seconds and then spontaneously went into atrial fibrillation.The issue ceased when the cable was detached from the catheter.The cable was replaced and the same catheter was reconnected to the new cable without any errors appearing.Hemodynamic support in the form of vasopressors for approximately 30 minutes was provided to the patient following the incident.The patient was cardioverted and the procedure was continued with no further issues with the patient.The patient also required an overnight stay that was not anticipated.The patient was reported to be in stable condition and was released the next day.The right atrium was about to be mapped and the patient had an existing dual chamber pacemaker that did not capture for a few seconds afterward and then reverted to magnet mode.It was examined afterwards and was found to be in working order.The physician believes there was current transfer from the piu through the ablation catheter.

Manufacturer Narrative

The product was discarded, therefore, no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Concomitant products: coolflow pump (model# m-5491-02 serial# (b)(4)).(b)(4) are related to the same incident.(b)(4).Event description continuation: the products involved were the ez steer thermocool sf nav catheter, c3 interface cable ¿ therapeutic, carto 3 system and stockert system.It is currently unknown which product contributed to the event and a complete investigation will be done to determine the causative device.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 03/20/2015.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4) it was reported that a patient, (b)(6), male, underwent an atrial flutter (afl) procedure with a c3 interface therapeutic cable and received an electrical shock, became asystolic and then went into atrial fibrillation which required hemodynamic support.A visual inspection was performed on the extension cable, and the cable was found in good condition, there was no failure that can result in a complaint.Proper cable pins in both connector plug and receptacle connectors, no bent pin or damaged receptacle was found.No cracks or scratches were found on connector plastic cover.Only minor findings were observed on the cable which do not compromised the cable functionality.Per the event, the cable was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.The cable was also evaluated for carto 3.The test catheter was connected to the reported cable was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The cable passed all specifications.The root cause of the serious injury remains unknown.

• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4588104
• MDR Text Key: 5481085
• Report Number: 2029046-2015-00056
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1286-03-S
• Device Catalogue Number: CR3434CT
• Device Lot Number: OEM_D-1286-03-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 85