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

Model Number	NS7TCCL174HS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A manufacturing record evaluation was performed for the finished device 17743795m number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old male patient underwent an atrioventricular reentrant tachycardia/wolff-parkinson-white syndrome (avrnt/wpw) ablation procedure with a navistar¿ electrophysiology catheter and suffered atrioventricular (av) heart block requiring surgical intervention (pacemaker implantation).During the case, an av heart block was confirmed by electrocardiogram (ecg).No radiofrequency was being delivered at the time of the event; however, the physician had ablated before the event occurred.The physician is undecided on what the cause of the adverse event was, he believes it may be caused either by the ablation or by maneuvering the sheath.The patient¿s condition did not improve, and the physician decided to implant a pacemaker.The patient was reported in stable condition after the intervention.It is unknown if extended hospitalization was required as a result of the adverse event.No biosense webster product malfunctions nor error messages were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
Upon internal review on (b)(6)2020 , it was discovered that in section b2 the checkmark for "is disability or permanent damage" was mistakenly omitted in the initial report.Due to the patient's pacemaker implantation, the "is disability or permanent damage" checkmark has been selected in this supplemental report.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-000730671.
Additional Manufacturer Narrative
On (b)(6) 2020, the product investigation was completed as no product was returned.It was reported that a 9-year-old male patient underwent an atrioventricular reentrant tachycardia/wolff-parkinson-white syndrome (avrnt/wpw) ablation procedure with a navistar¿ electrophysiology catheter and suffered atrioventricular (av) heart block requiring surgical intervention (pacemaker implantation).During the case, an av heart block was confirmed by electrocardiogram (ecg).No radiofrequency was being delivered at the time of the event; however, the physician had ablated before the event occurred.The physician is undecided on what the cause of the adverse event was, he believes it may be caused either by the ablation or by maneuvering the sheath.The patient¿s condition did not improve, and the physician decided to implant a pacemaker.The patient was reported in stable condition after the intervention.It is unknown if extended hospitalization was required as a result of the adverse event.No biosense webster product malfunctions nor error messages were reported.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, a manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10375837
• Report Number: 2029046-2020-01010
• Device Sequence Number: 19694654
• Product Code: DRF
• UDI-Device Identifier: 10846835008555
• UDI-Public: 10846835008555
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 07/14/2020

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: 10/08/2020
• Device Model Number: NS7TCCL174HS
• Device Catalogue Number: NS7TCCL174HS
• Device Lot Number: 17743795M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 08/06/2020; 09/11/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 08/07/2020; 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BRAND SHEATH
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 9 YR