MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number M-4800-01

Device Problems Overheating of Device (1437); Communication or Transmission Problem (2896)

Patient Problem No Code Available (3191)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an atrioventricular nodal reentrant tachycardia (avnrt) procedure, the customer experienced a non-mdr reportable signal loss and system overheating issues.The first issue (signal lost on carto system) is not reportable event since the all bs and ic electrograms were present on the ep recording system and the physician had signals to monitor patient heart rhythm therefore the risk to the patient is remote.The second issue is highly detectable and resolved by exchanging devices, such that it is not indicative of an mdr reportable event.However, this cause is being conservatively assessed as an mdr reportable malfunction because against the technical guidance of bwi technical support, the customer did not stop using the overheating device, potentially exposing the patient to risk.The customer continued to apply ablation energy through the overheating carto system.Investigation is still in progress.A supplemental report on device evaluation will be submitted.

Manufacturer Narrative

(b)(4) it was reported that during an atrioventricular nodal reentrant tachycardia (avnrt) procedure, during the first attempted use of the carto 3 system, it cycled through initialization several times and then error 1 persisted.All the body surface and intracardiac electrograms were present on the ep recording system, but all signals were missing on the carto 3 system.Early on a "current leakage error" appeared.At the point error 1 appeared, the biosense webster field representative exchanged the fiber optic cable and rebooted the system.While the system was cycling initialization, the patient interface unit (piu) lost power, no lights were illuminated on the front or back, and an "electrical smell" was reported.The procedure was continued without navigation, but the catheters were still connected.Pacing was successful.The biosense webster field representative contacted the biosense webster field service representative and asked if the piu could continue to be used for the procedure as a pass through for signals and radio frequency energy.The biosense webster field service representative advised to disconnect the piu from the patient and not apply radio frequency energy.The biosense webster field representative communicated this to the physician and staff; however, the procedure was continued without piu disconnection.The biosense webster field service representative arrived to the account regarding the issue.System powered on without issue.The biosense webster field service representative did confirm the electrical smell emanating from the piu when power was on or off.The biosense webster field service representative replaced the system as a dead on arrival (doa).The system was sent to the device manufacturer for investigation.The customer complaints related to initialization problem and current leakage error were confirmed.The location rx card was found faulty and caused both the reported issues.The lost power problem and electrical smell issues were not confirmed.The system was tested during a few days and passed safety, functional and visual tests.The device history record (dhr) review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5148296
• MDR Text Key: 28660317
• Report Number: 3008203003-2015-00083
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1