MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER¿ ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	F6QA252RT
Medical Device Problem Code	Material Separation (1562)
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.Manufacturer's reference number: (b)(6).
Event or Problem Description
It was reported that an unknown patient underwent atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a webster¿ electrophysiology catheter.The catheter shaft broke.During an avnrt procedure, while advancing the mapping catheter to the patient's heart, the catheter shaft broke and could not be situated in the patient's heart.A similar catheter was open and the procedure continue and ended successfully.No patient consequences.The damage did not result in wires being exposed or any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre-shaped.The sheath was a 6f.The catheter shaft breaking while inside of the patient is mdr-reportable.
Additional Manufacturer Narrative
On 2-oct-2021, 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.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 22-oct-2021, the product investigation was completed.It was reported that an unknown patient underwent atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a webster¿ electrophysiology catheter.The catheter shaft broke.During an avnrt procedure, while advancing the mapping catheter to the patient's heart, the catheter shaft broke and could not be situated in the patient's heart.A similar catheter was open and the procedure continue and ended successfully.No patient consequences.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the webster 4 pole.A manufacturing record evaluation was performed for the finished device 30485262m number, and no internal actions elated to the reported complaint condition were identified.The event described could not be confirmed as the as the device was found in good conditions.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 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: WEBSTER¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• 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: 12457990
• Report Number: 2029046-2021-01538
• Device Sequence Number: 11074069
• Product Code: LDF
• UDI-Device Identifier: 10846835007909
• UDI-Public: 10846835007909
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K892265
• 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): 11/11/2021

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: 12/14/2023
• Device Model Number: F6QA252RT
• Device Catalogue Number: F6QA252RT
• Device Lot Number: 30485262M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 10/02/2021; 10/22/2021
• Initial Report FDA Received Date: 09/12/2021
• Supplement Report FDA Received Date: 10/12/2021; 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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
• Patient Sex: Unknown