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

Catalog Number	D610DRP10RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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.(b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with a webster catheter and a broken tip with internal component exposure occurred during the procedure.The catheter was changed and the procedure was continued.The procedure was completed with no patient consequence.This event is mdr reportable because if the catheter integrity is not maintained there is a potential risk to the patient.
Additional Manufacturer Narrative
During analysis of the device, on (b)(6) 2018, it was discovered that the tip of the catheter was broken, metal exposed was observed.In addition, on (b)(6) 2018, scanning electron microscope analysis showed evidence of mechanical damage, stress marks and a hole on the surface of the anchor window.These finds are reportable due to potential risk to the patient.(b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a procedure with a webster catheter and a broken tip with internal component exposure occurred during the procedure.The returned device was visually inspected and the tip was found broken on the anchor window area.Per the damage observed a scanning electron microscope (sem) testing was performed and the results showed evidence of mechanical damage, stress marks and a hole on the surface of the anchor window.It is possible that the damage was generated with an unknown object.No other anomalies were 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 confirmed.Based on available analysis finding results, the damage observed does not appear to be caused by any internal bwi processes since the device was manufactured in accordance with documented specification and procedures.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 02/17/2018.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.Manufacturer's ref.No: (b)(4).

• Brand Name: WEBSTER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7259927
• Report Number: 2029046-2018-01176
• Device Sequence Number: 19079602
• Product Code: DRF
• UDI-Device Identifier: 10846835000238
• UDI-Public: 10846835000238
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K892265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/19/2018

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: 08/20/2020
• Device Catalogue Number: D610DRP10RT
• Device Lot Number: 17719161M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 01/19/2018; 03/15/2018; 03/15/2018
• Initial Report FDA Received Date: 02/09/2018
• Supplement Report FDA Received Date: 03/05/2018; 03/19/2018; 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1