MAUDE Adverse Event Report: BIOSENSE WEBSTER INC BI DIR 7FR DEFL CS CATH, NON-; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Catalog Number	BD710DF282RTS
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	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biosense webster inc.Product analysis lab received the device for evaluation.Upon initial visual inspection, no damage or anomalies observed.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.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a webster ® cs catheter with ez steer¿ technology (cs) catheter and a thrombus issue occurred.The physician noticed via intra-cardiac ultrasound that a clot had formed on the proximal electrodes on the cs catheter.When the catheter was removed, proximal electrodes deformity was also noticed.The procedure was then cancelled.No patient injury was reported.Multiple attempts have been made to obtain additional details.However, no further information has been made available.The observed thrombus has been assessed as an mdr reportable malfunction.
Additional Manufacturer Narrative
It was reported that a patient underwent an ablation procedure for atrial fibrillation with a webster ® cs catheter with ez steer¿ technology (cs) catheter and a thrombus issue occurred.The physician noticed via intra-cardiac ultrasound that a clot had formed on the proximal electrodes on the cs catheter.The investigational analysis completed 12/26/2019.The returned device was visually inspected and it was found in normal conditions.Per the event, the catheter was tested for electrical performance and it was found within specifications.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint cannot be confirmed.The catheter passed all specifications.Manufacture reference no: (b)(4).

• Brand Name: BI DIR 7FR DEFL CS CATH, NON-
• 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: 9454676
• Report Number: 2029046-2019-03984
• Device Sequence Number: 11529838
• Product Code: DRF
• UDI-Device Identifier: 10846835002416
• UDI-Public: 10846835002416
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/18/2019

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: 06/26/2022
• Device Catalogue Number: BD710DF282RTS
• Device Lot Number: 30251184M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1