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

Catalog Number	D134302
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.A manufacturing record evaluation was performed for the finished device 30163627l number, and no internal action was found during the review.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a lasso® nav eco catheter for which biosense webster¿s product analysis lab identified to be stuck in a deflected position.It was initially reported that during the procedure the lasso® nav eco catheter could not contract to variable sizes.There was no indication of how the issue was resolved.There was no patient consequence reported.The reported contraction issues are not mdr reportable since the loop contraction mechanism is not working properly, the user will not be able to use the device and will have to replace it.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.On (b)(6) 2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis observed there was no visual damage or anomalies.On (b)(6) 2019, during a second visual analysis the catheter was inspected and it was found in good conditions, no visual damages observed.However, it was noticed that catheter was stuck in a deflection position.This finding was reviewed and assessed as a reportable malfunction.This event was originally considered non reportable, however, bwi became aware of a reportable malfunction through visual inspection on (b)(6) 2018 and has reassessed this complaint as reportable.
Additional Manufacturer Narrative
It was initially reported that during the procedure the lasso® nav eco catheter could not contract to variable sizes.There was no indication of how the issue was resolved.There was no patient consequence reported.The reported contraction issues are not mdr reportable since the loop contraction mechanism is not working properly, the user will not be able to use the device and will have to replace it.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.On (b)(6) 2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis observed there was no visual damage or anomalies.On (b)(6) 2019, during a second visual analysis the catheter was inspected and it was found in good conditions, no visual damages observed.However, it was noticed that catheter was stuck in a deflection position.This finding was reviewed and assessed as a reportable malfunction.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found in good conditions.However, it was noticed that catheter was stuck on deflection position.For this condition, the manufacture team performed an investigation in order to find the root cause, the investigation results showed that this issue is not related to the manufacture process since at the moment to perform the failure investigation, the device was contracted/deflected and work according to specification, the device was disassembled and everything was found in good conditions.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed since the contraction mechanism functioned as intended.The root cause of the deflection stuck cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling/manipulation of the device, however, this cannot be conclusively determined.Manufacturer¿s ref # (b)(4).

• Brand Name: LASSO® NAV ECO 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: 8972561
• Report Number: 2029046-2019-03607
• Device Sequence Number: 226797
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K113213
• 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): 08/14/2019

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: 01/06/2022
• Device Catalogue Number: D134302
• Device Lot Number: 30163627L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1