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

Model Number FG540000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

(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 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 a paroxysmal atrial fibrillation procedure with a carto(r) 3 system and a map shift occurred with no error message, no patient movement and no cardioversion.It was reported that during procedure, external evaluation, there was a problem with inflation index.The value was not correct.They were able to see that it had a different value.They also mentioned a map shift.The procedure was completed with no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.With the information available, the map shift was assessed as not mdr reportable as there was no information if there was an error message that populated, patient movement and cardioversion.The issue with the inflation index was assessed as not mdr reportable.The issue was highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.Additional information was received on the event on 10/13/2020.No errors reported by the system.The map shift (approximately 5cm) was visually discovered by the physician during mapping.The map did not correspond to the one made initially.No cardioversion prior to catheter shift and no patient movement.The map shift with no error message, no patient movement and no cardioversion was reassessed as an mdr reportable malfunction.The awareness date for this reportable issue is 10/13/2020.

Manufacturer Narrative

The investigation was completed on (b)(6) 2020.It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a carto® 3 system and a map shift occurred.It was reported that during procedure, external evaluation, there was a problem with inflation index.The value was not correct.They were able to see that it had a different value.The issue is related to the software defect.The defect is being handled per software defect management procedure.They also mentioned a map shift.The procedure was completed with no patient consequence.No errors reported by the system.The map shift (approximately 5cm) was visually discovered by the physician during mapping.The map did not correspond to the one made initially.No cardioversion prior to catheter shift and no patient movement.The biosense webster, inc.Field representative performed the acceptance testing procedure test of the system with no solution.The customer requested the patient interface unit replacement due to the recurring map shift issue.The biosense webster, inc.Field representative replaced the patient interface unit/location pad kit successfully.System was tested and all tests passed.System was ready for clinical use.The biosense webster, inc.Field representative performed a case support after the patient interface unit replacement.No issue appeared during this procedure.The replaced patient interface unit/location pad kit was sent to the device manufacturer for investigation/repair.The replaced parts were investigated.The reported map shift issue was not confirmed.Several problems were found during the rma process: damaged pins in the different patient interface unit connectors, damaged slot for the ecg card, defective magtx card and damaged connector on the location pad cable.All those defects are not related to the reported issue and could not cause a map shift.Furthermore, the same map shift issue was reported again after the patient interface unit/location pad kit replacement that confirms that the reported map shifts were not hardware related.Investigation request was opened by the device manufacturer for the reported issue.No study data could be obtained for this particular map shift; however, the study data was obtained for the same issue which occurred later and reported under manufacturer¿s reference number (b)(4) / manufacturer report number 2029046-2020-01811.The issue was investigated.It was found that the user mapped with a smart touch catheter at high alternating metal levels.These metal levels were near the warning level and sometimes beyond it.Yet acquire action is enabled.The source of the metal on the catheter is not clear as the patch metal levels were quite low and stable.Performing the acquire action under significantly different metal levels create non consistency in the map known as map shift.A manufacturing record evaluation was performed for the carto 3 system s/n (b)(6), and no internal actions related to the reported complaint condition were identified.An internal corrective action has been opened to investigate map shifts.In addition, an internal corrective action for damaged connectors on backplane cards has been opened to investigate the issue with the damaged patient interface unit ports.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 10776368
• MDR Text Key: 230695742
• Report Number: 2029046-2020-01620
• 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
• Report Date: 10/06/2020

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
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 01/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1