MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO® NAV ECO VARIABLE 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	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biosense webster, inc.Product 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.A manufacturing record evaluation was performed for the finished device 30120350l number, and no internal action was found during the review.(b)(6).Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with a lasso® nav eco variable catheter and the biosense webster, inc.Product analysis lab noted that the catheter tip was stuck in a fully deflected position.Initially it was reported that the end of the catheter was broken.Therefore, the catheter was exchanged.There was no considerable delay in the surgery.It was not known if the procedure was completed successfully.There was no patient consequence reported.Upon request, additional information was received on the event.No wires exposed.No lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre-shaped.The preface sheath 8f ref 301803m was used during the procedure.Per the response received that there were no wires exposed or lifted or sharp rings, this event was assessed as not reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and discovered on march 28, 2019 that the catheter tip was stuck in a fully deflected position.The handle manipulating the curve was stuck as well.This event was originally considered non-reportable, however, biosense webster, inc.Became aware of the returned condition of the catheter tip stuck in a fully deflected position on march 28, 2019 and have reassessed the event as reportable.
Additional Manufacturer Narrative
Investigation summary: it was reported that a patient underwent a procedure with a lasso® nav eco variable catheter.It was reported that the end of the catheter was broken.Therefore, the catheter was exchanged.There was no considerable delay in the surgery.It was not known if the procedure was completed successfully.There was no patient consequence reported.Upon request, additional information was received on the event.No wires exposed.No lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre-shaped.The preface sheath 8f ref 301803m was used during the procedure.The device was inspected and it was found stuck in a fully deflected position and no damage on the shaft was observed.For this condition, the manufacture team performed an investigation in order to find the root cause.The investigation results showed that the slug component was detached from the piston slot but the manufacturing steps were followed as required.Therefore, this issue cannot be related to the manufacture process.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed since no damage was observed.The root cause of the slug detachment causing the stuck condition 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 and manipulation of the device; however, this cannot be conclusively determined.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
During an internal review on april 23, 2019, it was noted that ¿manufacturer address street line 1¿ on the 3500a initial report needed correction.It was initially submitted as ¿31 technology drive¿.The correct address is ¿33 technology drive¿.Therefore, ¿manufacturer address street line 1¿ has been re-populated.Manufacturer¿s reference number: (b)(4).

• Brand Name: LASSO® NAV ECO VARIABLE 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: 8529598
• Report Number: 2029046-2019-03009
• Device Sequence Number: 1928662
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 02/28/2019

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: 10/02/2021
• Device Catalogue Number: D134302
• Device Lot Number: 30120350L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 11/06/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 04/25/2019; 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1