MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	1085122RT
Medical Device Problem Codes	Entrapment of Device (1212); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was that an unknown patient underwent an atrial flutter right (r-afl) ablation procedure with a webster¿ electrophysiology catheter.During insertion of the catheter the catheter was twisted and damaged.The catheter was difficult to remove and the doctor had to do several maneuvers to remove it.The doctor was raising the catheter into the patient, and suddenly the catheter was twisted and damaged and the doctor had to do several maneuvers to remove it.He was finally been able to remove it from the patient without consequences.The procedure was successfully completed.The damage did not result in wires/internal components being exposed or lifted or sharp rings.It was difficult to advance during the insertion of the catheter to the coronary sinus, so physician decide to remove the catheter and it was difficult as well because he noticed under x-ray catheter shaped was bent.Finally he was able to remove the catheter out the patient.The doctor always pre-shapes the catheter before insertion.The sheath used was a abbott short sheath 5fr.Shaft bent is not mdr-reportable.Medical device entrapment with excessive manipulation required is mdr-reportable.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).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 1-jun-2022, the product investigation was completed.It was that an unknown patient underwent an atrial flutter right (r-afl) ablation procedure with a webster¿ electrophysiology catheter.During insertion of the catheter the catheter was twisted and damaged.The catheter was difficult to remove and the doctor had to do several maneuvers to remove it.Device evaluation details: visual inspection testing was performed, in accordance with bwi procedures and the catheter failed due to the shaft being found bent.A dimensional test was performed, and the outer diameters of the device were found within specifications.There is no condition on the catheter that could be related to the entrapment of the catheter during the procedure.It should be noted that product failure is multifactorial.A manufacturing record evaluation was performed for the finished device 30658055l number, and no internal actions related to the reported complaint condition were identified.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 (b)(6) 2022, 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).

• Brand Name: WEBSTER¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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 ; 6465917981
• MDR Report Key: 14059556
• Report Number: 2029046-2022-00764
• Device Sequence Number: 14640720
• Product Code: DRF
• UDI-Device Identifier: 10846835000177
• UDI-Public: 10846835000177
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 08/25/2022
• 2 Devices were Involved in the Event: 1 2

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: 10/11/2024
• Device Model Number: 1085122RT
• Device Catalogue Number: 1085122RT
• Device Lot Number: 30658055L
• 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: 03/16/2022
• Supplement Date Received by Manufacturer: 04/09/2022; 06/01/2022; 08/24/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 04/26/2022; 06/20/2022; 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• 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: ABBOTT SHORT SHEATH 5FR.
• Patient Sex: Unknown