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

Catalog Number	F5QA005CT
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi failure 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.Concomitant products: carto 3 system, us catalog #: unknown, serial #: unknown.(b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with a webster catheter.It was described that the webster catheter was visualized upside down on the carto 3 system.The catheter cable was changed, but the issue did not resolve.The webster catheter was changed and the issue resolved.The procedure was continued and subsequently completed.The visualization issue was assessed as not reportable.The user will have to replace the catheter in order to complete the case.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster failure analysis lab received the device for evaluation.It was discovered on (b)(6) 2018 that electrode ring #2 was sharp at approximately 1.1 cm from the distal tip.The sharp electrode was assessed as a reportable malfunction.
Additional Manufacturer Narrative
The device history record was provided on 9/12/2018.The device history record (dhr) for the lot number 30085757m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(4).
Additional Manufacturer Narrative
Investigation summary: it was reported that a patient underwent a procedure with a webster catheter.It was described that the webster catheter was visualized upside down on the carto 3 system.The catheter cable was changed, but the issue did not resolve.The webster catheter was changed and the issue resolved.The procedure was continued and subsequently completed.The device was inspected and the ring 2 was found damage with sharp edges.Additionally, a scanning electron microscope (sem) testing was performed on the damage area and the results showed evidence of mechanical damage on the surface of the ring and a sharp edge was found.It is possible that the damage was generated with an unknown object.No other anomalies were observed.Then, the catheter outer diameter was measured and it was found within specification.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint was not confirmed.The root cause of the damage on electrode cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the manipulation of the device, however, this cannot be conclusively determined.Manufacturer's reference number: (b)(4).

• Brand Name: WEBSTER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7831563
• Report Number: 2029046-2018-02005
• Device Sequence Number: 19121519
• Product Code: DRF
• UDI-Device Identifier: 10846835007183
• UDI-Public: 10846835007183
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K892265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,litera
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2018

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: 06/26/2021
• Device Catalogue Number: F5QA005CT
• Device Lot Number: 30085757M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 09/12/2018; 11/28/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 09/13/2018; 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1