MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	D610DRP10RT
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a webster¿ electrophysiology catheter and an issue of foreign material was encountered.An issue of foreign matter was reported along with what was described as a ¿protrusion¿ on the distal tip of the catheter.However, review of a photo provided, it was determined that the protrusion was actually the device¿s anchor window and not a protrusion.The anchor window is part of the catheter¿s design.A second catheter was used to complete the operation.There was no patient consequence since the device was not used in the patient.This event is considered mdr reportable for the foreign matter issue reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
The product has not returned for analysis, however, a picture(s) 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.Initial reporter phone: (b)(6).Manufacturer's ref.#: (b)(4).
Additional Manufacturer Narrative
On 16-jan-2022, additional information was received from the customer confirming the protrusion previously reported was actually the catheters anchor window which is there by design.There is no issue of protrusion or foreign material visible through the protrusion.There is no product issue.As such, this event will no longer be considered to be mdr reportable.Manufacturer's ref # (b)(4).

• Brand Name: WEBSTER¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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: 13121586
• Report Number: 2029046-2021-02277
• Device Sequence Number: 4845439
• Product Code: DRF
• UDI-Device Identifier: 10846835000238
• UDI-Public: 10846835000238
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K892265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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 Model Number: D610DRP10RT
• Device Catalogue Number: D610DRP10RT
• Device Lot Number: 30569043M
• 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: 12/07/2021
• Supplement Date Received by Manufacturer: 01/16/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: DEF 6F,P10,D,STD,R10,92CM
• Patient Sex: Unknown