MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128211

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 06/08/2023

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that a carto system was used with cryo ablation catheter.During cooling the roof with cryo ablation catheter, blood pressure dropped from 100 to 40, and pericardial fluid was checked and found to be accumulating.A pericardial drainage was conducted.The patient was moved to the ward after condition stabilized.Timing was during cooling of the roof with cryo ablation catheter.Atrial septal puncture was performed.Ablation was not performed before pericardial effusion or tamponade was detected.There was no steam pop observed.An irrigation catheter was not used.The doctor's judgment on health hazard was that it was non-serious (moderate/minor).Causal relationship between the product and the event is unknown.Only cryoablation was performed.This event is being reported against the mapping catheter since it has direct contact with cardiac tissue and cannot be dissociated from being a contributor to the effusion.Since it was not indicated what mapping catheter was utilized prior to the ablation, this event is being reported against the pentaray for now, until further clarification is received on the specific mapping catheter that was used.

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that a carto system was used with cryo ablation catheter.During cooling the roof with cryo ablation catheter, blood pressure dropped from 100 to 40, and pericardial fluid was checked and found to be accumulating.A pericardial drainage was conducted.The patient was moved to the ward after condition stabilized.Timing was during cooling of the roof with cryo ablation catheter.Atrial septal puncture was performed.Ablation was not performed before pericardial effusion or tamponade was detected.There was no steam pop observed.An irrigation catheter was not used.The doctor's judgment on health hazard was that it was non-serious (moderate/minor).Causal relationship between the product and the event is unknown.Only cryoablation was performed.This event is being reported against the mapping catheter since it has direct contact with cardiac tissue and cannot be dissociated from being a contributor to the effusion.Since it was not indicated what mapping catheter was utilized prior to the ablation, this event is being reported against the pentaray for now, until further clarification is received on the specific mapping catheter that was used.Additional information was received on 27-jul-2023.It was reported that the outcome of the adverse event is improved.Transseptal puncture was performed with rf needle.Cryoablation was performed prior to noting the pericardial effusion.The event occurred during the ablation phase.An irrigated catheter was not used.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device 30973001l number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 05-sep-2023.It was reported that the physician¿s opinion on the cause of this adverse event was that it was procedure related and believed the issue occurred when the cryoballoon contacted the roof.The patient did not require extended hospitalization.The patient¿s condition has since improved.The physician¿s name was provided.Therefore, the e.Initial reporter section was updated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 15-nov-2023.It was reported that in this case, when the cardiac tamponade occurred, radiofrequency (rf) ablation with the thermocool smarttouch sf (stsf) catheter was not performed.Only cryo-balloon ablation was conducted.However, the stsf was inserted in the patient¿s body to perform rf ablation in combination with cryo-balloon ablation.With the additional information received, this event has been re-assessed as non mdr reportable against any biosense webster inc.(bwi) devices.Although bwi devices were inside the patient's body, this event should be captured under the cryoablation catheter.This is because the adverse event occurred during ablation phase (no rf ablation was performed - only cryo-balloon ablation was conducted).In addition, the event should be captured on the cryoablation catheter to align with physician's opinion on the cause of the adverse event, which was that the issue occurred when the cryoballoon contacted to the roof.As such, h 6.Medical device problem code has been updated.In addition, the concomitant product section was updated and thermocool smarttouch sf (thmcl smtch sf bid, tc, d-d) was added.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: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17274202
• MDR Text Key: 318549125
• Report Number: 2029046-2023-01456
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2023

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: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30973001L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 07/10/2023; 09/05/2023; 11/15/2023
• Supplement Dates FDA Received: 08/04/2023; 09/28/2023; 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LASSO NAV 2515,22P SPLITHANDLE; SOUNDSTAR ECO SMS 8F CATHETER; THMCL SMTCH SF BID, TC, D-D; UNK BRAND CRYO ABLATION CATHETER; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Required Intervention