MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number	BD710FJ282CT
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	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a webster cs catheter and there was an open pouch seal issue.When opening the catheter, the packaging was already opened.The catheter was replaced and the issue resolved.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The event was assessed as a mdr reportable open pouch seal issue.
Additional Manufacturer Narrative
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
The investigation was completed on 14-feb-2022.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30667051m and no internal action related to the complaint was found during the review.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
• 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: 13467148
• Report Number: 2029046-2022-00229
• Device Sequence Number: 14420860
• Product Code: DRF
• UDI-Device Identifier: 10846835002423
• UDI-Public: 10846835002423
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/07/2022

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: 10/19/2024
• Device Model Number: BD710FJ282CT
• Device Catalogue Number: BD710FJ282CT
• Device Lot Number: 30667051M
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 02/06/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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