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

Model Number	BD710FJ282RTS
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biosense webster inc.Product analysis lab received the device for evaluation.Upon initial inspection, fiber like material was observed on distal tip of catheter.The observed fiber coincides with what was initially reported.The observed foreign material has been assessed as an mdr reportable malfunction.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.A manufacturing record evaluation was performed for the finished device and no internal actions were found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a webster ® cs catheter with ez steer¿ technology, and a foreign material issue occurred.It was reported that during the ablation procedure, the distal electrodes of the webster cs catheter were not working, and the distal end of the catheter was not being visualized on the carto 3 system.It was also noted that there was visible small debris of about 2 mm on the distal end of the catheter when removed from the body.No char or clot was observed.The physician wiped off the catheter.There¿s no information regarding how the case was completed.It is unknown if the debris were present before or after the catheter was introduced into the patient¿s body.The physician did not feel any resistance while introducing or retracting the catheter from the sheath.No physical damage was observed on the distal end of the catheter.No patient consequences were reported.No further details are available.The observed foreign material has been assessed as an mdr reportable malfunction.
Additional Manufacturer Narrative
It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a webster ® cs catheter with ez steer¿ thechnology, and a foreign material issue occurred.It was reported that during the ablation procedure, the distal electrodes of the webster cs catheter were not working, and the distal end of the catheter was not being visualized on the carto 3 system.The investigational analysis completed 3/3/2020.The device was visually inspected and fiber like material was found on distal tip of catheter.During a second closer inspection, foreign material was observed on the dome.The electrical feature was tested and no issues were observed.A fourier transform infrared spectroscopy test (ftir) was performed and results showed that foreign material is primarily composed of a biological-based material, presumably human tissue.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint regarding distal electrodes not working and the visualization issue were not confirmed.However, the foreign material reported was confirmed.Thereafter, it was clarified that the observed foreign material was biological.The root cause of the biological material found on the catheter tip could be related to the procedure.Manufacture reference no: (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: 9674133
• Report Number: 2029046-2020-00188
• Device Sequence Number: 18927290
• Product Code: DRF
• UDI-Device Identifier: 10846835002430
• UDI-Public: 10846835002430
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/13/2020

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 Expiration Date: 09/27/2021
• Device Model Number: BD710FJ282RTS
• Device Catalogue Number: BD710FJ282RTS
• Device Lot Number: 30124473M
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM