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

Catalog Number D134301

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2018

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.The device history record (dhr) for the lot number 17749774l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant product: thermocool smarttouch sf, us catalog #: d134805, lot #: 17752360l.(b)(4).

Event Description

It was reported that a patient , underwent a procedure with a lasso® nav eco variable catheter.After the lasso® nav eco variable catheter was removed from the patient, it was noticed that some of the coating was stripped off and there was also a kink towards the loop.There was no patient consequence reported.Response received confirmed that the damage found resulted in wires being exposed.The damage did not result in any lifted or sharp rings.There was resistance while removing the catheter.The damage was observed where the shaft of the catheter meets the loop.The sheath is not known.The issue described on the lasso® nav eco variable catheter of the wires being exposed has been assessed as a reportable malfunction.It was also reported that the thermocool smart touch sf catheter stopped fully deflecting towards the curve.The thermocool smart touch sf catheter was replaced and the issue resolved.This issue was assessed as not reportable as the user will not be able to use the device and will have to replace it.The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.

Manufacturer Narrative

The biosense webster inc.Failure analysis lab received the device for evaluation on 3/28/2018.During the initial visual inspection, it was discovered that the shaft was kinked.The bent/kink was observed right next to the handle.There were no wires exposed.This returned catheter condition was assessed as not reportable.If there¿s a slight bent of the shaft; however, the integrity of the catheter is not compromised, then the potential risk that it could cause or contribute to a death or serious injury is remote.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.No: (b)(4).

Manufacturer Narrative

Correction to follow-up #1.Initially, we reported that during the initial visual inspection, it was discovered that the shaft was kinked.The bent/kink was observed right next to the handle.There were no wires exposed.However, the correct first visual inspection is that the catheter was found in normal condition.Upon further assessment, the catheter was found to have some folds on the spine cover without exposed parts and electrode ring# 20 was slightly crushed without sharp edges.This issue was assessed as not reportable.If the electrode rings are smooth or dull.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.Investigation summary: it was reported that a patient , underwent a procedure with a lasso® nav eco variable catheter.After the lasso® nav eco variable catheter was removed from the patient, it was noticed that some of the coating was stripped off and there was also a kink towards the loop.There was no patient consequence reported.Response received confirmed that the damage found resulted in wires being exposed.The damage did not result in any lifted or sharp rings.There was resistance while removing the catheter.The damage was observed where the shaft of the catheter meets the loop.The sheath was not known.The device was visually inspected and it was observed in normal conditions, then, during the second visual inspection it was observed some folds on spine cover without exposed parts and electrode ring #20 was found slightly damaged without sharp edges.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.On line, 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 on the loop cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the procedure, however, this cannot be determined.Manufacturer's reference number: (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: 7272412
• MDR Text Key: 100254047
• Report Number: 2029046-2018-01191
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2018

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: 10/16/2020
• Device Catalogue Number: D134301
• Device Lot Number: 17749774L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/14/2018
• Supplement Dates Manufacturer Received: 01/22/2018; 01/22/2018
• Supplement Dates FDA Received: 04/10/2018; 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1