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

Model Number	D135304
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a webster cs catheter with auto id technology and the deflection became stuck.The webster cs catheter with auto id technology catheter was not steerable anymore.The curve went smaller and the physician could not steer the catheter back to original position.The procedure was completed without patient consequence.There was no surgery delay and no fragments were generated.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a webster cs catheter with auto id technology and the deflection became stuck.The webster cs catheter with auto id technology catheter was not steerable anymore.The curve went smaller and the physician could not steer the catheter back to original position.The procedure was completed without patient consequence.There was no surgery delay and no fragments were generated.Device evaluation details: on 5-sep-2023, the device was returned to biosense webster inc (bwi) for evaluation.A visual inspection evaluation and deflection test of the returned device were performed following bwi procedures.The evaluation has been completed.Visual analysis revealed no damage or anomalies on the device.A deflection test was performed and the curve was deflecting within specifications.No deflection stuck condition was observed during the analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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 23-jun-2023, additional information was received indicating yes, it was in a full deflection and was not steerable anymore.It was possible to turn and push the knob but there was no effect to the catheter.There was no difficulty removing the catheter.There was no ring electrode or other physical damage.Additionally, the product has not been returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.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 ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a webster cs catheter with auto id technology and the deflection became stuck.The webster cs catheter with auto id technology catheter was not steerable anymore.The curve went smaller and the physician could not steer the catheter back to original position.The procedure was completed without patient consequence.Device investigation details: a picture was provided by the customer for evaluation to aid in the investigation.The picture was evaluated following biosense webster's procedures.According to picture provided by the customer, the picture does not provide sufficient information related to the deflection issue reported by the customer, therefore, no results can be obtained from it.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint was not confirmed based on the picture received.The device has not been returned for analysis and a root cause cannot be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.Note: h6.Investigation findings code of ¿appropriate term/code not available (c22)¿ used to represent the photo analysis results.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: 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17181194
• Report Number: 2029046-2023-01349
• Device Sequence Number: 15118164
• Product Code: DRF
• UDI-Device Identifier: 10846835009989
• UDI-Public: 10846835009989
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/22/2023

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: 03/08/2026
• Device Model Number: D135304
• Device Catalogue Number: D135304
• Device Lot Number: 31021249M
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 06/23/2023; 07/17/2023; 09/05/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/12/2023; 08/02/2023; 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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