MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Catalog Number	BD710FJ282CT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Cardiac Tamponade (2226); No Code Available (3191)
Date of Event	01/07/2019
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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an ablation procedure for paroxysmal atrial fibrillation on which a webster ® cs catheter with ez steer® technology and auto id was used, and suffered cardiac tamponade (requiring pericardiocentesis and surgical intervention) and sepsis.During the procedure, the patient¿s blood pressure dropped.Cardiac tamponade was confirmed by echo.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardium.The patient also required a coronary sinus (cs) repair via pericardial window.Part of the diaphragm had to be replaced as a result of this as well.Extended hospitalization was required as a result of the adverse event.Patient¿s condition worsened as is suspected of developing sepsis.Physician¿s opinion regarding the cause of the adverse event is that the cs was perforated by the webster ® cs catheter with ez steer® technology and auto id.Additional information has been requested to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
Initially it was reported that the patient suffered a cardiac tamponade (requiring pericardiocentesis and surgical intervention) and sepsis.However, additional information was received on february 14, 2019 confirming that sepsis did not occur.The patient had brief fever.Therefore, removed sepsis as a patient consequence under patient codes.Manufacturer¿s reference number: (b)(4).

• Brand Name: WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8282790
• Report Number: 2029046-2019-02609
• Device Sequence Number: 1259347
• Product Code: DRF
• UDI-Device Identifier: 10846835002423
• UDI-Public: 10846835002423
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• 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
• Report Date (Section B): 01/11/2019

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 Catalogue Number: BD710FJ282CT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 02/25/2019
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 122