MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D135303
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a webster cs catheter with auto id technology.The catheter had foreign material on the catheter.The cs catheter had yellow tape stuck to the end of the catheter and the staff didn't want to use it because they felt that it would get stuck when inserted into the sheath.When the catheter was replaced, the issue resolved.It was shipped with the orange tape not the normal blue tape.There were no wires and/or braid being exposed and no lifted or sharp rings.The catheter was never inserted in the patient.There was no detachment.The catheter felt different where the tape placed onto.The shaft ¿ handle transition is where the catheter differs from past cs catheters.Foreign material on usable length of catheter is mdr-reportable.
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
On 24-apr-2022, bwi received additional information clarifying a comment previously reported in section b5 of the 3500a initial."it was shipped with the orange tape not the normal blue tape¿ is related to the part marked in red a photo sent to bwi.The bwi product analysis lab will analyze this photo but the analysis is not yet done.Additionally, on 19-may-2022, the bwi 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.Manufacturer's reference number: (b)(4).

• Brand Name: WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14189325
• Report Number: 2029046-2022-00871
• Device Sequence Number: 11882433
• Product Code: DRF
• UDI-Device Identifier: 10846835009972
• UDI-Public: 10846835009972
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K080425
• 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): 05/22/2022

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: 02/01/2025
• Device Model Number: D135303
• Device Catalogue Number: D135303
• Device Lot Number: 30725071M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2022
• 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: CARTO 3 SYSTEM.; SOUNDSTAR CATHETER.
• Patient Sex: Unknown