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

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  malfunction  

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 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
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10330811
• MDR Text Key: 201887038
• Report Number: 2029046-2020-00950
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835002423
• UDI-Public: 10846835002423
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1