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

Model Number	BD710DF282RTS
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned for analysis, however, pictures were 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.(b)(4).
Event or Problem Description
It was reported that a patient was going to undergo an atrial fibrillation (afib) ablation procedure with a webster ® cs catheter with ez steer¿ technology and a foreign material was found in the cs catheter sterile packaging.It was reported that inside the sterile cs catheter packaging, there was a little piece of fuzz in it.The foreign material appeared to be a small black piece of fuzz but the package was not opened after noticing this.The catheter was not used on the patient.No adverse patient consequences were reported.The foreign material inside the packaging (outside of spec) was assessed as mdr reportable.
Additional Manufacturer Narrative
The photo analysis was completed on (b)(6) 2021.It was reported that a patient was going to undergo an atrial fibrillation (afib) ablation procedure with a webster ® cs catheter with ez steer¿ technology and a foreign material was found in the cs catheter sterile packaging.It was reported that inside the sterile cs catheter packaging, there was a little piece of fuzz in it.The foreign material appeared to be a small black piece of fuzz but the package was not opened after noticing this.The catheter was not used on the patient.No adverse patient consequences were reported.According to the pictures provided by the customer, foreign material appeared to be inside the pouch.A manufacturing record evaluation was performed for the finished device [30655129m] number, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed from the photo analysis.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: pc-(b)(4).
Additional Manufacturer Narrative
The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 26-jan-2022.The device evaluation was completed on 08-feb-2022.It was reported that a patient was going to undergo an atrial fibrillation (afib) ablation procedure with a webster ® cs catheter with ez steer¿ technology and a foreign material was found in the cs catheter sterile packaging.It was reported that inside the sterile cs catheter packaging, there was a little piece of fuzz in it.The foreign material appeared to be a small black piece of fuzz, but the package was not opened after noticing this.The catheter was not used on the patient.No adverse patient consequences were reported.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.According to pictures provided by the customer, foreign material appears inside the pouch.However, the device was returned without its original package; therefore, the test cannot be performed.A manufacturing record evaluation was performed for the finished device [30655129m] number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.The instructions for use contain the following warning: inspect the catheter packaging before 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).

• 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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12961572
• Report Number: 2029046-2021-02136
• Device Sequence Number: 14815122
• Product Code: DRF
• UDI-Device Identifier: 10846835002416
• UDI-Public: 10846835002416
• 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,Followup
• Report Date (Section B): 02/23/2022

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: 09/27/2024
• Device Model Number: BD710DF282RTS
• Device Catalogue Number: BD710DF282RTS
• Device Lot Number: 30655129M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 12/14/2021; 01/26/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 01/07/2022; 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2021
• 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
• Patient Sex: Unknown