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

Model Number	D610FR252RT
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial flutter right (r-afl) ablation procedure with two webster catheters and it was observed that there was internal components exposed issues.It was reported that the webster (decanav) catheter had a strange kink on the shaft of the catheter all the way distal in between the bipolar electrode; the section even allows for the interworkings of the catheter to be seen.The physician requested to have the catheter replaced.The replacement catheter was from the same lot number and had the same issue between the electrodes.There was no patient consequence reported.Additional information was received.The internal components of the catheter were visible but did not appear to be fully exposed.No lifted or sharp rings as far as they could tell.Catheter was never inserted into a sheath; the damage was recognized before being inserted into the sheath.Catheter was never inserted into a sheath; the damage was recognized before being inserted into the sheath.Two devices had this failure, but they just used the second catheter.No visible damage on the packaging.The event was assessed as mdr reportable under both the webster catheters for internal components exposed issues.
Additional Manufacturer Narrative
The investigation was completed on 07-jan-2023: 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 30856006m number, and no internal actions 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
• 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15749489
• Report Number: 2029046-2022-02769
• Device Sequence Number: 15033196
• Product Code: DRF
• UDI-Device Identifier: 10846835004335
• UDI-Public: 10846835004335
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2023

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: 06/21/2025
• Device Model Number: D610FR252RT
• Device Catalogue Number: D610FR252RT
• Device Lot Number: 30856006M
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 01/07/2023
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 01/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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: 1EF 6F,10P,F,SD,252,R10,92CM
• Patient Sex: Unknown