MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CELSIUS ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Model Number	D6TCBL252RT
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
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.Note: the date of event is unknown, as such, the event date has been populated with 1/1/2021.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a celsius¿ electrophysiology catheter and a foreign material issue occurred.It was reported that the catheter tip, had a strange bulge.It looks like the typical glue, but much more.This was discovered prior to use.The location of the foreign material is between 2nd and 3rd pole from the distal end of the catheter.The damage did not result in wires being exposed or any lifted or sharp rings.The catheter was changed and the procedure was successfully completed with no patient consequence.
Additional Manufacturer Narrative
On (b)(6)2021, the bwi product analysis lab received the complaint device for evaluation.The product 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.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a celsius¿ electrophysiology catheter and a foreign material issue occurred.It was reported that the catheter tip, had a strange bulge.It looks like the typical glue, but much more.This was discovered prior to use.The location of the foreign material is between 2nd and 3rd pole from the distal end of the catheter.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a general inspection through the visual inspection.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the celsius¿ electrophysiology catheter.A manufacturing record evaluation was performed and no internal action related to the complaint was found during the review.The instructions for use contain the following warning stated in the instruction for use (ifu): do not use the catheter if the small vent area at the connector end of the handpiece is clogged, since air may be forced into the catheter lumen and into the bloodstream although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: CELSIUS ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12038368
• Report Number: 2029046-2021-00965
• Device Sequence Number: 14480735
• Product Code: LPB
• UDI-Device Identifier: 10846835004649
• UDI-Public: 10846835004649
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P950005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2021

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: 06/23/2023
• Device Model Number: D6TCBL252RT
• Device Catalogue Number: D6TCBL252RT
• Device Lot Number: 30390852M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/20/2021; 08/05/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 07/27/2021; 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1