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

Catalog Number D134301

Device Problems Signal Artifact/Noise (1036); Dent in Material (2526); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

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) 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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a lasso® nav eco variable catheter and a there was electrode damage.When the physician removed the lasso catheter from the sheath he felt resistance.When the catheter was reinserted electrodes 7 and 8 had noisy signals.The catheter was removed and upon inspection of the catheter it was found that the electrodes were damaged.There were no wires or braid exposed.However, there was lifted and or sharp rings.The catheter was replaced with a pentaray catheter and the procedure was continued and subsequently completed.There was no patient consequence.The resistance and the noise issues are not mdr reportable because the risk to the patient is low.However, the damaged electrodes are mdr reportable because if the electrode ring edges appear to be sharp or rough, this may potentially cause patient injury.

Manufacturer Narrative

On 3/26/2018, the biosense webster failure analysis lab discovered rings of electrodes #2, #4, #8, #10 are damaged and spine cover was broken near electrode 8.These findings are also mdr reportable.(b)(4).

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 03/05/2018.The analysis has begun but is not completed at this time.It was discovered that electrode 10 is lifted and is creating sharp edges.This finding coincides with the reported event and is mdr reportable, because if the electrode is dented, lifted or ring edges appear to be sharp or rough, this may pose a potential risk to the patient.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation procedure with a lasso® nav eco variable catheter and a there was electrode damage.The returned device was visually inspected and the electrode #10 was found lifted with sharp edges, then, during the second visual inspection the electrodes #2, #4, #8, #10 and the spine cover were found damage.Then, electrical test was performed and the catheter failed, no electrical readings were observed on electrode # 8 and # 10 due to the damage found.Then, the catheter outer diameter was measured and it was found within specification.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 the manufacturing process, 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 cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Manufacturer's ref no: (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: 7145601
• MDR Text Key: 96127003
• Report Number: 2029046-2017-01304
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009637
• UDI-Public: (01)10846835009637(11)170901(17)200831(10)17726798L
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2017

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: 08/31/2020
• Device Catalogue Number: D134301
• Device Lot Number: 17726798L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 12/05/2017; 03/26/2018; 03/26/2018
• Supplement Dates FDA Received: 03/16/2018; 04/17/2018; 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1