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

Catalog Number	BD710FJ282RTS
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with webster ® cs catheter with ez steer¿ technology and a clot was visualized on the intracardiac ultrasound.The catheter was removed and the case continued without further issue.The procedure was completed without patient consequence.The system did not display any error messages and the physician did not experience any product issues during the procedure.It was also confirmed that the issue did not occur during the ablation.Heparinized saline anticoagulant was administered to the patient.The patient has not exhibited any neurological symptom since the procedure was completed.The clot issue has been assessed as a reportable malfunction.
Additional Manufacturer Narrative
On 8/2/2018, the biosense webster failure analysis lab received the device for evaluation.Device evaluation summary: upon receipt, the device was visually inspected.It was found to be in good condition.An electrical test was performed, which the catheter passed.No electrical malfunctions were observed.A deflection test was performed, and the catheter was found to be deflecting correctly.No other testing was performed.The customer complaint cannot be confirmed.Manufacturer¿s reference number: (b)(4).

• Brand Name: WEBSTER ® CS CATHETER WITH EZ STEER¿ THECHNOLOGY
• 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: 7695343
• Report Number: 2029046-2018-01799
• Device Sequence Number: 19220963
• Product Code: DRF
• UDI-Device Identifier: 10846835002430
• UDI-Public: 10846835002430
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: BD710FJ282RTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1