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

Catalog Number D134301

Device Problems Material Split, Cut or Torn (4008); Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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) for the lot number 30013455l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(4).

Event Description

It was reported a patient underwent an atrial fibrillation procedure with a lasso nav eco variable catheter and the catheter tip partially separated exposing the catheter¿s internal components.It was reported the physician noticed the lumen had collapsed on the proximal side of the lasso nav eco variable catheter (below the loop).Catheter¿s internal structure was visible.Procedure continued with a new catheter.No patient consequence was reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The issues of the catheter partially separating and the catheter breaking inside the patient are mdr reportable malfunctions.

Manufacturer Narrative

It was reported the physician noticed the lumen had collapsed on the proximal side of the lasso® nav eco variable catheter (below the loop).Catheter¿s internal structure was visible.Procedure continued with a new catheter.No patient consequence was reported.Device evaluation details: the device was inspected and the lasso loop was found damaged and internal parts were exposed.Deflection and contraction test were performed and the deflection was working properly, however, the catheter contraction failed.Due to the catheter condition, the manufacture team performed an investigation in order to find the root cause.The investigation results showed that this issue its not related to the manufacture process since the puller wire was not damaged and it was correctly assembly with ferule, as well as the contraction coil.Afterwards, the braided wire was not attached to polyimide and did not cover the intended area, this is the most probable reason that this catheter failed, however, there is no evidence of puller wire broken, ferrule detached, open coils, stretched coils, it is observed that the tension occurred in the spine cover, meaning that the piece went through excessive stress during the surgical procedure.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.The root cause of the damage observed on the lasso loop cannot be related to the manufacture process since there is evidence that the device was manufactured in accordance with documented specification and procedures, the damage could be related to the handling of the device during the procedure.Additional information was received from the customer stating that the catheter was pre-shape and resistance to remove/insert the catheter was observed.The instructions for use (ifu) states that no excessive force must be applied to advance or withdraw the catheter through the guiding sheath, when resistance is encountered.Correction: after review of the complaint and the product¿s returned condition the h6.Device code has been corrected from 4043 (separation problem) to 4008 (material split, cut or torn).Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On 2/4/2019, additional information about the event was received.The customer stated that there was resistance during manipulation of the catheter.The catheter was pre-shaped as this is a lasso® nav eco variable catheter.The customer also confirmed that the damage resulted in exposed internal components.Sheath information is unknown.On 2/22/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis identified ¿lasso loop is damaged.Internal parts are exposed.¿ this finding continues to be an mdr reportable malfunction.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.# (b)(4).

• Brand Name: LASSO® NAV ECO VARIABLE CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8192748
• MDR Text Key: 131937896
• Report Number: 2029046-2018-02490
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: 10846835009637
• Combination Product (y/n): N
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2021
• Device Catalogue Number: D134301
• Device Lot Number: 30013455L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 02/04/2019; 03/25/2019
• Supplement Dates FDA Received: 02/26/2019; 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1