MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. NOGA-STAR¿ CARDIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	120708S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ventricular Tachycardia (2132)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on (b)(6) 2018.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.Still pending is the manufactured date and the expiration date.Therefore, a supplemental report will be submitted to update.Expiration date.Manufactured date.Manufacturer's ref # (b)(4).
Event or Problem Description
It was reported that a patient underwent an unspecified procedure with a noga-star¿ cardiology catheter and suffered ventricular tachycardia requiring medication.During the procedure, the patient went into ventricular tachycardia.Lidocaine was administered, the catheter was repositioned, and the catheter was removed.Remainder of the procedure was aborted.Patient was reported to be in stable condition.Multiple attempts have been made to obtain clarification to this complaint.No further information has been made available.Should more information become available, the complaint will be reassessed and notes will be updated.
Additional Manufacturer Narrative
It was reported that during the procedure, the patient went into ventricular tachycardia.Lidocaine was administered, the catheter was repositioned, and the catheter was removed.Remainder of the procedure was aborted.Patient was reported to be in stable condition.Product evaluation details: upon receiving the catheter carto c3 recognition and c3 carto coil disconnection test were performed, and the catheter passed.Electrical test was performed including leakage and resistance and were found to be within specification.The 13/25 pin test was performed and passed.The eeprom was checked and was found to be within specification.The lab confirmed all test results passed and found the catheter working properly.Complaint was not confirmed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Additional Manufacturer Narrative
On 6/20/2018, the device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Additionally, the manufactured date and expiration date were provided.Device manufacture date have been populated.Manufacturer's ref # (b)(4).

• Brand Name: NOGA-STAR¿ CARDIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7620659
• Report Number: 2029046-2018-01709
• Device Sequence Number: 1623688
• Product Code: DRF
• UDI-Device Identifier: 10846835002058
• UDI-Public: 10846835002058
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K954390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 120708S
• Device Lot Number: 17717059M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 06/20/2018; 07/18/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 06/28/2018; 08/15/2018
• 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: Life Threatening; Required Intervention