MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; CARDIAC MAPPING SYSTEM

Catalog Number FG540000J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

Multiple attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Since there is no clarification, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.Since no serial number was provided, no device history record (dhr) review could be performed.(b)(4).Fda report numbers 2029046-2018-01256 and 2029046-2018-01271 are related to the same event.

Event Description

It was reported that a female patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation and a cavotricuspid isthmus (cti) ablation procedure for atrial flutter with a carto 3 system and suffered a cardiac tamponade requiring pericardiocentesis.During pvi and superior vena cava (svc) ablation, visitags displayed as expected.During cti ablation, visitags did not display as expected, as multiple visitags appeared (despite the catheter being in a stable position) and the visitags did not turn from white to red.There were no error messages on the carto.Although the physician expressed concern regarding the multiple visitags, ablation continued in the same location since the visitags did not turn from white to red.The patient became hypotensive and a cardiac tamponade was detected.There were no steam pops noted.Pericardiocentesis was performed and yielded approximately 300 ml of blood.Patient was reported to be in stable condition.There is no information regarding extended hospitalization.Patient outcome has improved.There were no patient factors cited that may have contributed to the adverse event.Physician indicated that the visitags did not display as expected, and since there were multiple visitags and the color did not change as expected, ablation continued in the same location.Physician¿s opinion regarding the cause of the adverse event is that it was related to a bwi product malfunction, specifically the abnormal appearance of the visitags.Transseptal puncture was performed with an unspecified needle.There is no sheath information.Generator was set on power control mode.There is no information regarding generator parameters, generator settings, power titration, overall ablation time at the site of injury, last ablation cycle time at the site of injury, irrigated catheter flow setting, or anticoagulation during the procedure.Ablation was performed with a dragging technique.Force-time integral was 100-200.Tag size was 2 mm.Visitag settings included stability range of 2 mm, 5 seconds, force-over-time (fot) 5 grams, and 25 percent.There is no information regarding spi value, catheter proximity, or catheter zeroing.There were no errors observed on any bwi equipment during the procedure.

Manufacturer Narrative

Additional information was received on march 13, 2018.The serial number of the carto 3 system used is (b)(4).This device was manufactured november 14, 2012.Catalog number for this device is fg540000j.The corresponding fields have been updated.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

Additional information was received on august 21, 2018.Device history record review was performed by the manufacturer and no anomalies, which are related to the reported issue were noted in manufacturing or servicing of this equipment.In addition, a correction as lot #.Was left off last supplemental report.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

It was reported that a female patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation and a cavotricuspid isthmus (cti) ablation procedure for atrial flutter with a carto 3 system and suffered a cardiac tamponade requiring pericardiocentesis.In addition, visitags did not display as expected.Field service engineer could not duplicate the issue.Tank test and system operation test was performed, and proper operation was confirmed.The system was ready for use.The issue was investigated at the device manufacturer.The study data was received and investigated.It was found that system worked as designed.The unstable ablation in the cavotricuspid isthmus (cti) map caused the creation of multiple visitags, and this was the expected system behavior.The dragging was so prominent that even with stability range of 10 mm the tags were constantly breaking.A very long stable ablation was found in the rps\rrf region with very high force values.The user used custom range for the fti color bar.In this coloring mode the user could not recognize tags with very high fti values.Device history record review was performed by the manufacturer and no anomalies, which are related to the reported issue were noted in manufacturing or servicing of this equipment.Manufacturer reference number: (b)(4).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7298260
• MDR Text Key: 101001429
• Report Number: 2029046-2018-01271
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FG540000J
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention