MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D135303
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
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)(4).
Event or Problem Description
It was reported that an unknown patient underwent an unknown ablation procedure with a webster cs catheter with auto id technology.There was an overhang at the distal tip of the catheter that was presumably shaft material.Placement of the cs catheter was not possible.When the catheter was removed from the patient, an overhang at the distal tip of the catheter, probably due to production, was observed.This is presumably shaft material.There was no patient consequences.The damage did not result in wires being exposed or any lifted or sharp rings.There was difficulty during insertion because the cs-catheter could not be placed in the cs.The issue was found directly at the distal end.During the manufacturing process, the electrodes of the catheter are presumably embedded in the shaft material.This must have resulted in a material overhang at the distal electrode of the catheter.The rubber overhang covered the entire distal electrode and hung over it (approx.5mm).The tip or any other components were not detached from the device.No patient consequences were reported.Catheter shaft detachment/breakage inside the patient is mdr-reportable.
Additional Manufacturer Narrative
On 10-jun-2022, bwi received additional information regarding the initial reporter information in section e.The section with the physician's information has been updated accordingly.E1 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 6-jul-2022, the product investigation was completed.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis revealed a foreign material on the dome, a fourier transform infrared spectroscopy test (ftir) was performed and determined that is primarily composed of a biological-based material, presumably a human tissue or fluid.A manufacturing record evaluation was performed for the finished device 30766474m number, and no internal action was found during the review.The issue reported by the customer was confirmed.It can be the normal result process.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 CS CATHETER WITH AUTO ID TECHNOLOGY
• 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 ; 646591-7981
• MDR Report Key: 14606274
• Report Number: 2029046-2022-01212
• Device Sequence Number: 17422183
• Product Code: DRF
• UDI-Device Identifier: 10846835009972
• UDI-Public: 10846835009972
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2022

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: 03/22/2023
• Device Model Number: D135303
• Device Catalogue Number: D135303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 06/10/2022; 07/06/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/05/2022; 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• 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