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

Model Number FG540000

Device Problems Signal Artifact/Noise (1036); Fitting Problem (2183); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) -persistent ablation procedure with a carto 3 system.The patient was under general anesthesia and a transseptal puncture had been made when the case was cancelled due to failure of the carto 3 system.During the procedure, map 1-2 was damaged, and every time the catheter was plugged in, everything would shut down, with no signal or noise on every signal catheter.An anesthesia monitor was available to monitor the patient¿s heart rhythm (ecg signal).The procedure could not be finished.The patient fully recovered with no residual effects and no extended hospitalization was required.The physician¿s opinion regarding the cause of this adverse event is that this was a biosense webster, inc.(bwi) product malfunction where map 1-2 port (back plane) was damaged.The bwi field service engineer, while on site, discovered a physically damaged short location pad cable.The cable and backplane card was replaced.Also, 2 pin boxes had bent pins inside the connector.Since the event is life threatening and required intervention to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Based on the completed mre, the h4.Device manufacture date has been populated with 12/13/2009.It was reported that a patient underwent an atrial fibrillation (afib) -persistent ablation procedure with a carto 3 system.The patient was under general anesthesia and a transseptal puncture had been made when the case was cancelled due to failure of the carto 3 system.During the procedure, map 1-2 was damaged, and every time the catheter was plugged in, everything would shut down, with no signal or noise on every signal catheter.An anesthesia monitor was available to monitor the patient¿s heart rhythm (ecg signal).The procedure could not be finished.The patient fully recovered with no residual effects and no extended hospitalization was required.The physician¿s opinion regarding the cause of this adverse event is that this was a biosense webster, inc.(bwi) product malfunction where map 1-2 port (back plane) was damaged.Device evaluation details: the bwi field service engineer (fse), while on site, confirmed a physically damaged map port located on the backplane card.The fse replaced the damaged backplane card with a new one.Pm/atp tests were performed after backplane card replacement.All tests passed and the issue was resolved.The system was in service and ready for use.The backplane card htc rma investigation cannot be performed due to damaged backplane card was scrapped in the emea quest warehouse.The history of customer complaints reported during the last year associated with carto 3 system # 10233 was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the carto 3 system # 10233, and no internal actions related to the reported complaint condition were identified.An internal corrective action has been opened to address this issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

Manufacturer's reference number: (b)(6) on 5/27/2021, during an internal review of the reported event, it was determined that the reported event of "absence of treatment" is to be considered a non-serious patient event and not mdr reportable since the physician did not consider that cancelling the procedure (absence of treatment) represented an increased risk to the patient.There was no exacerbation of patient¿s disease.No additional intervention nor prolonged hospitalization were required.

• 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: 11516936
• MDR Text Key: 240681656
• Report Number: 2029046-2021-00381
• 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: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG540000
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 05/03/2021; 05/27/2021
• Supplement Dates FDA Received: 05/21/2021; 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER; UNKNOWN BRAND CATHETER
• Patient Outcome(s): Other