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

Catalog Number	NS7TCJL174HS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Complete Heart Block (2627); No Code Available (3191)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 during supraventricular tachycardia (svt) ablation procedure in a 66 year old female patient with navistar¿ electrophysiology catheter, the patient developed heart block following radio frequency requiring insertion of permanent pacemaker.During the ablation phase, post use of biosense webster, inc.Products, the physician felt that due to all of the patient arrhythmias it was medical acceptable to proceed with avnrt ablation that was extremely close to the atrioventricular node (avn) region with the full understanding that it could cause complete heart block.The physician¿s opinion in respect to the cause of the event is that it was related to patient¿s condition.The patient is improved after pacemaker implantation.The physician noted that due to the difficult arrhythmia that proceeding with pacemaker at that time instead of the future date was appropriate.The patient required extended hospitalization due to surgical intervention (normal after pacemaker implantation).
Additional Manufacturer Narrative
Investigation summary: it was reported that during supraventricular tachycardia (svt) ablation procedure in a (b)(6) patient with navistar¿ electrophysiology catheter, the patient developed heart block following radio frequency requiring insertion of permanent pacemaker.During the ablation phase, post use of biosense webster, inc.Products, the physician felt that due to all of the patient arrhythmias it was medical acceptable to proceed with avnrt ablation that was extremely close to the atrioventricular node (avn) region with the full understanding that it could cause complete heart block.The patient is improved after pacemaker implantation.The patient required extended hospitalization due to surgical intervention (normal after pacemaker implantation).The device was visually inspected and it was found in good conditions.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Additionally, deflection test was performed and it was found within specifications, the catheter was deflecting correctly.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacturer's reference number: (b)(4).

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9373787
• Report Number: 2029046-2019-03934
• Device Sequence Number: 16919996
• Product Code: DRF
• UDI-Device Identifier: 10846835008586
• UDI-Public: 10846835008586
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 06/25/2021
• Device Catalogue Number: NS7TCJL174HS
• Device Lot Number: 30081644M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention