MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number	NS7TCFL174HS
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2018
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.The device history record (dhr) for the lot number 30044105m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer¿s ref # (b)(4).
Event or Problem Description
It was reported a patient underwent an ablation procedure with a navistar¿ electrophysiology catheter and a deflection issue occurred.During the operation, the catheter could not deflect to the specification.A second catheter was used to complete the operation and there were no reported consequence or injury to the patient.This initially reported event has been assessed as not reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On (b)(6) 2018, the biosense webster inc¿s failure analysis lab (fal) received the device for evaluation and initial visual analysis identified, ¿the tip is bent and the peek housing is lifted.¿ these findings have been reviewed and assessed as mdr reportable malfunctions.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction on (b)(6) 2018 and have reassessed the event as reportable.
Additional Manufacturer Narrative
It was reported a patient underwent an ablation procedure with a navistar¿ electrophysiology catheter and a deflection issue occurred.A second catheter was used to complete the operation and there were no reported consequence or injury to the patient.On 11/07/2018, the biosense webster inc¿s failure analysis lab (fal) received the device for evaluation and initial visual analysis identified, ¿the tip is bent and the peek housing is lifted.¿ these findings have been reviewed and assessed as mdr reportable malfunctions product evaluation details: the device was inspected and bent tip was observed, also the peek housing was found lifted.A deflection test was performed and the catheter failed.A failure analysis was performed and the catheter was dissected and the puller wire was found broken from the tip area.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.On line, functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint was confirmed.The root cause of puller wire broken cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.The root cause of the damage on peek housing could be related to the handling of the device, however, this cannot be conclusively determined.Manufacturer¿s ref # (b)(4).

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8135634
• Report Number: 2029046-2018-02410
• Device Sequence Number: 16709664
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: 10846835000610
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P990025
• 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
• Report Date (Section B): 11/07/2018

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: 04/10/2021
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 30044105M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1