MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	NS7TCJL174HS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation.The analysis has begun but is not 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 or Problem Description
It was reported that an unknown patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a navistar¿ electrophysiology catheter.The patient suffered heart block which required steroids and pacing.During the ablation they caused a heart block mobitz type ii.They were about 10 mm away from the his while they were ablating.The caller states they lost conduction to the ventricle.They paced the patient via the rv catheter and they had retrograde conduction.They knew they did not take out the fast pathway.They think they may have stimulated the parasympathetic nervous system.The patient was being monitored and she did start to recover a little bit.The reporter states they will find out tomorrow if the patient made a full recovery.When the patient left the lab they were not being paced.The reporter states the patient received some isopropyl.The patient had some prolongation and they are slowly recovering.The patient was starting to pace on their own and they were in first-degree heart block.The patient is stable and they are staying overnight for observation.The physician felt they may have stimulated the parasympathetic nervous system and the treatment was steroids.The physician was planning to give the patient the steroid for the treatment.They used a 4mm nav, cs, and an hra, his, and rv catheter.It was also reported that during the procedure, in the beginning, they received a 105 catheter sensor error.The staff stated the physician had disconnected and reconnected the catheter from the cable and the error was displayed.They replaced the cable and the issue was resolved and the case continued.Magnetic sensor error is not mdr-reportable.Since the event is life threatening and required cancellation of the procedure to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.
Additional Manufacturer Narrative
On 5-nov-2021, the product investigation was completed.It was reported that an unknown patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a navistar¿ electrophysiology catheter.The patient suffered heart block which required steroids and pacing.During the ablation they caused a heart block mobitz type ii.They were about 10 mm away from the his while they were ablating.The caller states they lost conduction to the ventricle.They paced the patient via the rv catheter and they had retrograde conduction.They knew they did not take out the fast pathway.They think they may have stimulated the parasympathetic nervous system.The patient was being monitored and she did start to recover a little bit.The reporter states they will find out tomorrow if the patient made a full recovery.When the patient left the lab they were not being paced.The reporter states the patient received some isopropyl.The patient had some prolongation and they are slowly recovering.The patient was starting to pace on their own and they were in first-degree heart block.The patient is stable and they are staying overnight for observation.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the navistar catheter.Per the event, several tests were performed.The magnetic and temperature features were tested and no issues were observed.In addition, the product was deflecting correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30495906m number, and no internal actions related to the complaint were found during the review.No malfunction was observed during the product analysis.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(60 2021, bwi received additional information regarding the event.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event: patient condition.Intervention provided: rv pacing and isopropyl.Patient outcome of the adverse event: fully recovered (no residual effects).Additionally, section a was updated.The patient is female.The patient's date of birth is (b)(6) 1975.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: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12613461
• Report Number: 2029046-2021-01738
• Device Sequence Number: 1414547
• Product Code: DRF
• UDI-Device Identifier: 10846835008586
• UDI-Public: 10846835008586
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P990025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2024
• Device Model Number: NS7TCJL174HS
• Device Catalogue Number: NS7TCJL174HS
• Device Lot Number: 30495906M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 10/12/2021; 11/05/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/03/2021; 11/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; UNSPECIFIED CORONARY SINUS CATHETER; UNSPECIFIED HIS; UNSPECIFIED HRA; UNSPECIFIED RV CATHETER.; CARTO 3 SYSTEM; UNSPECIFIED CORONARY SINUS CATHETER; UNSPECIFIED HIS; UNSPECIFIED HRA; UNSPECIFIED RV CATHETER.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female