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

Catalog Number	DLN1215CT
Medical Device Problem Codes	Hole In Material (1293); Device Issue (2379)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2017
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.(b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso® nav catheter.Initially, it was reported that the deflection was inadequate during the procedure as the catheter could not deflect.The catheter was exchanged.No patient consequences were reported.This event was assessed as not reportable as the catheter was unable to deflect, the user will not be able to use the device and will have to replace it.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 failure analysis lab received the catheter for analysis and discovered during the assessment on january 24, 2018 that the tip of catheter was received broken at 117.5 cm from the handle and internal parts were exposed.This returned catheter condition was assessed as a reportable malfunction.Therefore, the awareness date for this issue is january 24, 2018.
Additional Manufacturer Narrative
Correction to the initial report.Adding the device history record that was provided on january 29, 2018.The device history record (dhr) for the lot number 17346117l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso® nav catheter.Initially, it was reported that the deflection was inadequate during the procedure as the catheter could not deflect.The catheter was exchanged.No patient consequences were reported.The returned device was visually inspected and the tip was found broken with internal parts exposed.Then per the event, a deflection test was performed and the catheter passed.Then, per the damage observed a scanning electron microscope (sem) testing was performed and the results showed evidence of mechanical damage on the surface of the tip.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 cannot be confirmed.The damage observed does not appear to be caused by any internal biosense webster, inc.Processes since there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturer's reference number: (b)(4).

• Brand Name: LASSO® NAV CATHETER
• 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: 7246526
• Report Number: 2029046-2018-01118
• Device Sequence Number: 16401231
• Product Code: DRF
• UDI-Device Identifier: 10846835006780
• UDI-Public: 10846835006780
• Combination Product (Y/N): N
• PMA/510(K) Number: K093376
• 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
• Report Date (Section B): 01/24/2018

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: 09/30/2018
• Device Catalogue Number: DLN1215CT
• Device Lot Number: 17346117L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018; 01/24/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 02/21/2018; 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1