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

Model Number M-4800-01

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, the bs ecg trunk cable connector was broken and the ecg signals on the carto 3 system and on the ep recording system were noisy.The lab staff complained that the cable was not long enough and that is why the cable broke.The bs-ecg trunk cable was used from the save the case kit to resolve the issue.There was no patient injury reported in this procedure.Upon request, additional information was provided on the event.The issue occurred probably during pre-op but realized it when they started the procedure because the signals were noisy.The noise occurred on all the channels, including the 12 leads of bs ecgs and all ic (intracardiac) recordings.The noise occurred on both the carto 3 system and the ep recording system at the same time.The noise was quite disturbing and because their next patient was a vt patient, they said they need much clearer signals to be confident enough to evaluate them.The physician was able to complete the procedure with the noise because of his years of experience and being able to differentiate the noise from normal potentials.Per the severity of the noise on all signals on both the carto 3 system and the recording system at the same time is indicative of a reportable event.

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.(b)(4).

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 3583895
• MDR Text Key: 4192756
• Report Number: 3008203003-2014-00004
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K090017
• 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
• Report Date: 01/06/2014

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
• Initial Date Manufacturer Received: 01/06/2014
• Initial Date FDA Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1