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

Model Number NS7TCCL174HS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 07/14/2020

Event Type  Injury  

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 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.

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.

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
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10375837
• MDR Text Key: 202012445
• Report Number: 2029046-2020-01010
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008555
• UDI-Public: 10846835008555
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 08/06/2020; 09/11/2020
• Supplement Dates FDA Received: 08/07/2020; 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND SHEATH
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 9 YR