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

Model Number	BD710FJ282CT
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found in good conditions.The electrodes were inspected and are in good conditions, near the electrode #1 has the anchor slot that is part of the design and is in normal conditions.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (b)(4).
Event or Problem Description
It was reported that a patient underwent atrial flutter right (r-afl) ablation procedure with a webster ® cs catheter with ez steer® technology and auto id where damaged electrode issue occurred.It was reported that the distal pole had a partial electrode.When removing out of the body looks like the electrode is missing or may be buried in the plastic.The cable was replaced without resolution.A different port was also tried but the issue persisted.The webster ® cs catheter with ez steer® technology and auto id was replaced and the issue resolved.The case continued.There was no report of patient consequence or extended hospitalization.

• Brand Name: WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY 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: 10330811
• Report Number: 2029046-2020-00950
• Device Sequence Number: 10996909
• Product Code: DRF
• UDI-Device Identifier: 10846835002423
• UDI-Public: 10846835002423
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 06/30/2020

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: 02/13/2023
• Device Model Number: BD710FJ282CT
• Device Catalogue Number: BD710FJ282CT
• Device Lot Number: 30344420M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1