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

Catalog Number NS7TCDL174HS

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

Patient Problems Arrhythmia (1721); Not Applicable (3189)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.(b)(4).

Event Description

It was reported that a (b)(6) female patient underwent an ablation procedure for atrial tachycardia with a navistar¿ electrophysiology catheter and suffered a heart block requiring a temporary pacemaker.Five seconds post-ablation in the right atrium, a 2nd degree heart block occurred.Remainder of procedure was aborted.A temporary pacemaker was implanted, but was not used until a previously-scheduled surgery the following day.Patient was reported to be in stable condition.Patient was under observation.Patient did not require extended hospitalization as a result of the adverse event.It was noted that any additional hospitalization was secondary to the surgery that was previously scheduled for the following day.Patient outcome is improved.Medical history includes heart transplant x 2.Physician¿s opinion regarding the cause of the adverse event is that it was related to the patient¿s condition.Generator was set on temperature control mode at 50 watts and 70 degrees celsius.

Manufacturer Narrative

On 6/28/2018, it was discovered that the device history record review statement was inadvertently omitted from the initial 3500a report.As such, this correction mdr is being processed.The device history record (dhr) has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(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: 7550328
• MDR Text Key: 109454468
• Report Number: 2029046-2018-01604
• 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
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

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: 01/21/2021
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: 30006078M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 06/28/2018
• Supplement Dates FDA Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Weight: 100