MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number FG540000

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with carto® 3 system, and a no signal issue occurred.Initially, it was reported that during the procedure the electrocardiogram (ecg) could not be seen.No ecg signal was available for the physician to monitor the patient¿s heart rhythm.Unspecified cable replacement resolved the issue.No adverse patient consequences were reported.The observed no signal issue has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with carto® 3 system, and a no signal issue occurred.Initially, it was reported that during the procedure the electrocardiogram (ecg) could not be seen.The investigational analysis completed 2/19/2020.The hospital performed troubleshooting and found that defective body surface electrograms (bs ecg) cable caused the issue.The cable was replaced with a spare one, and as a result, the issue resolved.The field service engineer followed up on the complaint and confirmed that the replacement bs ecg cable was delivered to the account.The system is operational.The defective bs ecg cable was provided to the device manufacturer for investigation.The customer complaint about loss of all ecg signals was not confirmed.However, the channel v1 only was found defective.The rest of ecg channels were confirmed fully functional and their signals were visible are clear.In addition, according to biosense webster inc.(bwi) clarification, the cable was in use 3-4 years.This is much more than its expected life cycle.A manufacturing record evaluation was performed and no internal actions were identified.Manufacture reference no: (b)(4).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9435466
• MDR Text Key: 199478297
• Report Number: 2029046-2019-03968
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

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: FG540000
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1