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

Model Number NS7TCDL174HS

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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 Description

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a navistar¿ electrophysiology catheter and suffered atrioventricular (av) heart block requiring surgical intervention (pacemaker implantation).During the ablation phase, the patient went into av block.Ablation was stopped immediately; however, the sinus rhythm did not return even after 20 minutes.A temporary pacemaker was implanted.Reminder of the procedure was ended.The patient condition did not recover by the end of the procedure.The physician commented that the issue occurred due to the ablation and did not blame the product.It is unknown if prolonged hospitalization was required.No bwi product malfunction nor error messages were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this event required surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 2/3/2021, bwi received additional information regarding the event.The patient is a 46-year-old female.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: 11074953
• MDR Text Key: 223799803
• Report Number: 2029046-2020-01988
• 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: 12/03/2020

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 Model Number: NS7TCDL174HS
• Device Catalogue Number: NS7TCDL174HS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR