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

Model Number	D7TDL252RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: the section ¿initial reporter¿ information is currently unavailable.The only information available is the country of event.Follow up is in progress to obtain this information.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 (b)(6) female patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with a celsius¿ electrophysiology catheter and the catheter tip broke.It was reported that there was a fracture between the electrode tip.The surgery was not delayed due to the reported event.They changed the catheter when the event occurred and the procedure was successfully completed.Fragments were not generated.No other medical intervention was required.There was no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
Note: the section ¿initial reporter¿ information is currently unavailable.The only information available is the country of event.Follow up is in progress to obtain this information.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 (b)(6) female patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with a celsius¿ electrophysiology catheter and the catheter tip broke.It was reported that there was a fracture between the electrode tip.The surgery was not delayed due to the reported event.They changed the catheter when the event occurred and the procedure was successfully completed.Fragments were not generated.No other medical intervention was required.There was no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
On (b)(6)2022, additional information was received indicating the damage resulted in wires being exposed but no lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter since the device was not used on the patient due to the damage being found when the package was open.It has not yet been insert into the patient.The lot number for the device was reported to be 30465035m.Device evaluation details: on (b)(6)2022, the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted visual analysis of the returned device.The visual analysis of the returned sample revealed that the tip was found slightly bent.The ¿fracture¿ condition is actually part of the catheter¿s design and called the anchor window.A tilt test was performed, in accordance with bwi procedures.The catheter was found in the specification.In addition, the customer provided a picture of the complaint device to aid in the investigation.The picture shows the catheter tip, but does not provide sufficient information related to the reported event and therefore no result can be obtained from it.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The events described could not be confirmed and no issues were observed.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.The instructions for use (ifu) contain the following warnings and precautions: always pull the thumb knob back to straighten the catheter tip before insertion or withdrawal of the catheter.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
On 10-jan-2022, the details related to the initial reporter were received.As such, the appropriate fields in section e have been populated: (b)(6).Thailand please note, a character limit in field e1.Initial reporter address line 1 prompted the information to be minimized as such: 106 moo 4 lardkrabang ind esta 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13211610
• Report Number: 2029046-2022-00064
• Device Sequence Number: 13874713
• Product Code: LPB
• UDI-Device Identifier: 10846835000412
• UDI-Public: 10846835000412
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2022

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: 11/02/2023
• Device Model Number: D7TDL252RT
• Device Catalogue Number: D7TDL252RT
• Device Lot Number: 30465035M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 01/10/2021; 01/12/2021
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 01/12/2022; 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2020
• 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: DEF 7F,T,CC,4P,D,LE,252,RL,115
• Patient Age: 70 YR
• Patient Sex: Female