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

Model Number	BD710FJ282RTS
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial flutter right (r-afl) ablation procedure with a webster ® cs catheter with ez steer¿ technology and an open pouch seal issue occurred.It was reported that when opening the catheter for the first time the inside wrapping was opened already and the physician did not feel like the catheter was fully sterile.The catheter was replaced and the issue was resolved.The case continued.There was no patient consequence reported.Additional information was received on the event.The packaging was open.Almost as if there was no adhesive on the outer packaging.Meaning it was not fully sealed and therefore, the physician did not feel it was sterile.There was no issue with the way it was seated in the plastic.The event was assessed as a mdr reportable open pouch seal issue.
Additional Manufacturer Narrative
The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial flutter right (r-afl) ablation procedure with a webster ® cs catheter with ez steer¿ technology and an open pouch seal issue occurred.It was reported that when opening the catheter for the first time the inside wrapping was opened already and the physician did not feel like the catheter was fully sterile.The catheter was replaced and the issue was resolved.The case continued.There was no patient consequence reported.The investigation of the picture analysis was completed on 03-mar-2022.According to pictures provided by customer, an open pouch was observed.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13388654
• Report Number: 2029046-2022-00172
• Device Sequence Number: 12011674
• Product Code: DRF
• UDI-Device Identifier: 10846835002430
• UDI-Public: 10846835002430
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2022

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: 11/16/2024
• Device Model Number: BD710FJ282RTS
• Device Catalogue Number: BD710FJ282RTS
• Device Lot Number: 30686208M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BRAND CATHETER.
• Patient Sex: Unknown