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

Model Number	D7TCEL252RT
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with a celsius¿ electrophysiology catheter.The insulation is broken 16mm from the tip with wires exposed.It was reported that there was an insulation break near the proximal poles.No signal was detected on the catheter, despite changing the cable and the grounding patch.They replaced the cable, radiofrequency (rf) patch and the catheter.There was a five-minute procedural delay.The damage resulted in wires being exposed with no lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The issue occurred 16 mm from the tip and the catheter was not pre-shaped.No adverse patient consequence was reported.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The biosense webster, inc.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(4) during an internal review on 03-nov-2022, it was determined that the code of signal artifact (a090801) was inadvertently left off on the initial report mwr-01082022-0001231138.Therefore, the h6.Medical device problem code has been updated.
Additional Manufacturer Narrative
The device evaluation was completed on 01-dec-2022.It was reported that a patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with a celsius¿ electrophysiology catheter.The insulation is broken 16mm from the tip with wires exposed.It was reported that there was an insulation break near the proximal poles.No signal was detected on the catheter, despite changing the cable and the grounding patch.They replaced the cable, radiofrequency (rf) patch and the catheter.There was a five-minute procedural delay.The damage resulted in wires being exposed with no lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The issue occurred 16 mm from the tip and the catheter was not pre-shaped.No adverse patient consequence was reported.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, no damages or anomalies were observed, also, the photo does not provide sufficient information related to the ecg reported event and therefore no result can be obtained from it.The customer complaint was not confirmed based on the picture received.The celsius¿ 4mm electrophysiology catheter was returned to biosense webster (bwi) for evaluation.A visual inspection and electrical evaluation of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.An electrical test was performed, and an open circuit was found on the tip area.A manufacturing record evaluation was performed for the finished device number 30679118m, and no internal action related to the complaint was found during the review.The electrical issue was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.H6.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.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: 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
• 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 ; 646591-7981
• MDR Report Key: 15291457
• Report Number: 2029046-2022-01978
• Device Sequence Number: 19415531
• Product Code: LPB
• UDI-Device Identifier: 10846835006162
• UDI-Public: 10846835006162
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2022

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: 11/08/2024
• Device Model Number: D7TCEL252RT
• Device Catalogue Number: D7TCEL252RT
• Device Lot Number: 30679118M
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 10/10/2022; 12/01/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 11/07/2022; 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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: UNK BRAND CABLE; UNK BRAND CATHETER
• Patient Sex: Unknown