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

Model Number M-4800-01

Device Problems Image Display Error/Artifact (1304); Incorrect Measurement (1383); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)

Patient Problem No Code Available (3191)

Event Date 07/18/2014

Event Type  malfunction  

Event Description

It was reported that during re- pulmonary vein isolation (pvi) procedure, as soon as a lasso eco nav was connected to the piu, the green patches disappeared from the location setup and error 41, 42, 43 were displayed.When rebooting the piu for troubleshooting, piu was rebooting itself in a never ending loop.The physician also stated that the signals taken by cs catheter were measured in a wrong way also on the lasso catheter.Upon following up with the customer, bwi received additional information which is now indicative of a reportable event stated the carto procedure was cancelled and the customer stopped using the smart touch catheter and carto.The case was completed with a non nav ablation catheter without any patient consequence with 1 hour delay.A transseptal puncture was performed prior to the case delay.The physician considered the procedure delay caused a potential risk to this patient since no mapping or using of the carto navigation were possible.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).It was reported that during re- pulmonary vein isolation (pvi) procedure, as soon as a lasso eco nav was connected to the piu, the green patches disappeared from the location setup and error 41, 42, 43 were displayed.When rebooting the piu for troubleshooting, piu was rebooting itself in a never ending loop.The physician also stated that the signals taken by cs catheter were measured in a wrong way also on the lasso catheter biosense field service engineers could not be duplicated the issue on site.No issues found during system check.Suspected backplane was replaced.Full acceptance test procedure (atp) performed after backplane replacement.System is working properly.Backplane was sent to htc for investigation and the customer complaint was not confirmed.The card was tested with a few types of catheters(lasso eco nav tested too) at aquarium station , passed power bit tests and service jig utility tests- reported problem was not reproduced.However, during visual inspection, it was found bent pins in map(j27) and ref/deca (j28) connectors, the bent pins in connector j27 relates to complaint and could cause to reported problem "when the st catheter is connected, customer gets errors:41,42,43,44".A 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: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 20692 ; IS 20692
• Manufacturer (Section G): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 2069 2; IS 20692
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3999263
• MDR Text Key: 4954324
• Report Number: 3008203003-2014-00053
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• 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
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1