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

Model Number NS7TCDL174HS

Device Problems Contamination (1120); Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 (b)(6) year-old male patient (b)(6) underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with a navistar¿ electrophysiology catheter and suffered partial atrioventricular (av) heart block requiring cortisone and atropine administration.During the ablation, the physician heard a popping sound and immediately stopped the ablation.The physician suspected a steam pop occurred.There were no changes in the patient¿s blood pressure.Directly after the ablation, there were two v-a blocks.After this ablation (4th ablation), no further ablations were conducted.After about 5 minutes after the termination of the ablation, an a-v block was seen.Cortisone was administered to reduce edema.Atropine was also administered.After retracting the coronary sinus (cs) catheter, the av block started to recover.When the patient left the operating room, av block was not fully restored.He was kept for surveillance.About 30 minutes post-procedure, normal sinus rhythm was restored.Holter-monitoring was done over the weekend after the procedure.Only normal sinus rhythm was observed.Patient had fully recovered.No further interventions are planned.The patient was asked to contact the physicians if there is any sign of discomfort or similar.Prolonged hospitalization was not required.Physician¿s opinion regarding the cause of the event is that it was procedure related.It was also reported that upon product removal, small residue was found on the tip of the catheter, it was too small that the caller could not take a picture off it; however, the physician did not report any char.Since no char was confirmed, the material found on the device was assessed as not mdr reportable.The generator was used in temperature control mode with a max power at 50 watts and ablation time of 999 seconds.The target temperature was 70 degrees with a temperature cut off at 95 degrees.The impedance max cut-off was at 250 ohms and min cut-off at 50 ohms.

Manufacturer Narrative

Investigation findings code of "appropriate term/code not available" represents photo/video analysis.The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 5/5/2021.The device evaluation was completed on 5/19/2021.It was reported that a 68-year-old male patient (73.5kg) underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with a navistar¿ electrophysiology catheter and suffered partial atrioventricular (av) heart block requiring cortisone and atropine administration.During the ablation, the physician heard a popping sound and immediately stopped the ablation.The physician suspected a steam pop occurred.There were no changes in the patient¿s blood pressure.Directly after the ablation, there were two v-a blocks.After this ablation (4th ablation), no further ablations were conducted.After about 5 minutes after the termination of the ablation, an a-v block was seen.Cortisone was administered to reduce edema.Atropine was also administered.After retracting the coronary sinus (cs) catheter, the av block started to recover.When the patient left the operating room, av block was not fully restored.He was kept for surveillance.About 30 minutes post-procedure, normal sinus rhythm was restored.Holter-monitoring was done over the weekend after the procedure.Only normal sinus rhythm was observed.Patient had fully recovered.No further interventions are planned.The patient was asked to contact the physicians if there is any sign of discomfort or similar.Prolonged hospitalization was not required.Physician¿s opinion regarding the cause of the event is that it was procedure related.It was also reported that upon product removal, small residue was found on the tip of the catheter, it was too small that the caller could not take a picture off it; however, the physician did not report any char.Since no char was confirmed, the material found on the device was assessed as not mdr reportable.The generator was used in temperature control mode with a max power at 50 watts and ablation time of 999 seconds.The target temperature was 70 degrees with a temperature cut off at 95 degrees.The impedance max cut-off was at 250 ohms and min cut-off at 50 ohms.Device evaluation: according to the pictures provided by the customer, the temperature, impedance, power were observed on the generator.However, the pictures and video do not provide sufficient information related to the steam pop and v-a blocks, therefore could not be confirmed.Visual analysis of the returned product revealed that no damage or anomalies were observed on the navistar.Per the event, several tests were performed.The magnetic, electrical and temperature features of the device 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 30442614m lot number, and no internal action related to the complaint was found during the review.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instructions for use 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).

• Brand Name: NAVISTAR ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11708990
• MDR Text Key: 246776337
• Report Number: 2029046-2021-00639
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: 10846835000597
• Combination Product (y/n): N
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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 Expiration Date: 09/22/2023
• Device Model Number: NS7TCDL174HS
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: 30442614M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Manufacturer Received: 03/26/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 05/19/2021
• Supplement Dates FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7FR DECAN,11P,F,2.4MMLE,282MM,; UNKNOWN GENERATOR; 7FR DECAN,11P,F,2.4MMLE,282MM,; UNKNOWN GENERATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 73