MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. CELSIUS¿ ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	D6TCAL252RT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) for the lot number 17687043m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(6).Manufacturer¿s ref # (b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient with a diagnosis of tachycardia induced cardiomyopathy and in-utero svt underwent an ablation procedure with a celsius¿ electrophysiology catheter and suffered cardiac arrest requiring chest compressions.During and post ablation phase, the heart rate increased.Reminder of the procedure was aborted.Patient¿s blood pressure dropped, and the physician checked for an effusion.Pericardial effusion was not observed.The patient went into cardiac arrest and chest compressions were applied.The patient was reported to be in stable condition.Extended hospitalization was not required as a result of the adverse event.Patient¿s outcome is improved.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition-related.Per celsius® diagnostic/ablation deflectable tip catheter ifu, the usage of this device is indicated for catheter-based atrial and ventricular electrophysiologic mapping and for use with compatible radio frequency generators in adults and children 4 years of age or older in creating endocardial lesions during cardiac ablation procedures to treat arrhythmia.It is contraindicated to use the 8-french braided-tip catheter in children younger than 4 years old.

• Brand Name: CELSIUS¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8118093
• Report Number: 2029046-2018-02395
• Device Sequence Number: 16523050
• Product Code: LPB
• UDI-Device Identifier: 10846835004625
• UDI-Public: 10846835004625
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P950005
• 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
• Report Date (Section B): 11/02/2018

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: 05/31/2020
• Device Catalogue Number: D6TCAL252RT
• Device Lot Number: 17687043M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/29/2018
• 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
• Patient Age: 49 DA