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

Model Number	BD710FJ282CT
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biosense webster, inc.Product analysis lab received the device for evaluation.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a webster ® cs catheter with ez steer® technology and auto id and an issue with foreign material in the sterile package occurred.When the nurse took the package out of the box, a black piece of something circular and hard was noticed inside the sterile package.It could be felt from the back side of the packaging.The sterile package was not opened, and the device was not used on the patient.The catheter was exchanged, and the issue was resolved, and the case was continued without any further incident.There was no patient consequence.
Additional Manufacturer Narrative
The device evaluation was completed on 28-oct-2021.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a webster ® cs catheter with ez steer® thechnology and auto id and an issue with foreign material in the sterile package occurred.When the nurse took the package out of the box, a black piece of something circular and hard was noticed inside the sterile package.It could be felt from the back side of the packaging.The sterile package was not opened, and the device was not used on the patient.The catheter was exchanged, and the issue was resolved, and the case was continued without any further incident.There was no patient consequence.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the webster ® cs catheter with ez steer® thechnology and auto id.The device was returned without its original package, the foreign material described in the event was not returned.The test cannot be performed due to the catheter returned condition.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following warning stated: inspect the catheter packaging prior to use.If the package is open or damaged, return the catheter to biosense webster.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
A manufacturing record evaluation was performed for the finished device 30614232m number, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on (b)(6)-2021, it was noted that the manufacturing record evaluation was inadvertently left off on the follow-up report #mwr-28102021-0001068589.Therefore, this information was added on this report.

• Brand Name: WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID
• 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12693828
• Report Number: 2029046-2021-01821
• Device Sequence Number: 4239105
• Product Code: DRF
• UDI-Device Identifier: 10846835002423
• UDI-Public: 10846835002423
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2021

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: 08/01/2024
• Device Model Number: BD710FJ282CT
• Device Catalogue Number: BD710FJ282CT
• Device Lot Number: 30614232M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 11/23/2021; 11/23/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/23/2021; 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2021
• 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