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

Model Number	D7TEL252RT
Medical Device Problem Code	Break (1069)
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
The date of event was reported as unknown.The only information was reported as the event year as 2021, therefore, date of event has been populated as (b)(6) 2021.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 broken tip occurred.It was reported that the insulation (blue coating) was damaged already inside the package.There is a small hole (about 2mm) where the inner cables can be seen through because there is no blue coating on them.Damage was at the tip where the electrodes are located.Hole approx.2mm x 1mm in size, at the blue isolation.Catheter was not taken out of the packaging.There were no patient consequences.
Additional Manufacturer Narrative
On 5/25/2021, the bwi product analysis lab received the complaint device for evaluation.The device was visually inspected and found in good normal condition.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 the insulation (blue coating) was damaged already inside the package.There is a small hole (about 2mm) where the inner cables can be seen through because there is no blue coating on them.Damage was at the tip where the electrodes are located.Hole approx.2mm x 1mm in size, at the blue isolation.Catheter was not taken out of the packaging.There were no patient consequences.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.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.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) correction: it was noticed the incorrect date of (b)(6) 2021 was reported under section h10.Additional manufacturer narrative of the 3500a supplemental (follow-up) report # 1.The correct date was (b)(6) 2021.

• Brand Name: CELSIUS ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11700346
• Report Number: 2029046-2021-00619
• Device Sequence Number: 11628220
• Product Code: LPB
• UDI-Device Identifier: 10846835006247
• UDI-Public: 10846835006247
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P950005/S1
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2021

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: 06/08/2023
• Device Model Number: D7TEL252RT
• Device Catalogue Number: D7TEL252RT
• Device Lot Number: 30386049M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2021
• Supplement Date Received by Manufacturer: 05/26/2021; 06/25/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 06/08/2021; 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1