MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO® 2515 NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1343-01-S

Device Problems Sticking (1597); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

The bwi failure 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.(b)(4).Event description continuation: therefore, the electrode rings described as rough with some white material underneath them has been assessed as reportable as they may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath.In addition, dislodgement of the foreign material inside the patient poses a risk of embolus.The awareness date has been reset to june 16, 2016.

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso navigational variable eco catheter.At the beginning of the procedure, the loop of the catheter came out twisted from the swartz braided transseptal guiding introducer, ref 407362, 8.5 f sheath.The loop did not return to its original form.It was not possible to reintroduce the catheter again into the sheath.There was no difficulty in removing the catheter.There was no physical damage observed apart from the strange shape of the catheter which did not come back to its original shape.The catheter was not stuck in a contracted position.The knob/piston was unable to be turned and/or pushed up and down.The catheter was replaced and problem resolved.The procedure was completed with no patient consequences.This event was assessed as not reportable as the potential that this issue could cause or contribute to a serious injury, significant adverse event or death was remote.The product was received for analysis in the biosense webster failure analysis lab and it was discovered on (b)(6) 2016 that the loop was bent down sideways with the spine cover wrinkled.The distal side of ring #19 and #20 were rough with some white material underneath them.After follow-up, the physician stated that the condition observed was the lasso loop bent down sideways but he did not note the ring damage and material underneath the rings.The physician believes this might have occurred while removing the lasso out of the sheath too quickly the first time although he did not observe this condition at this moment.It was confirmed that there was no patient consequence.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso navigational variable eco catheter.At the beginning of the procedure, the loop of the catheter came out twisted from the swartz braided transseptal guiding introducer, ref 407362, 8.5 f sheath.The loop did not return to its original form.It was not possible to reintroduce the catheter again into the sheath.There was no difficulty in removing the catheter.There was no physical damage observed apart from the strange shape of the catheter which did not come back to its original shape.The catheter was not stuck in a contracted position.The knob/piston was unable to be turned and/or pushed up and down.The catheter was replaced and problem resolved.The procedure was completed with no patient consequences.The returned device was visually inspected and lasso loop was found bent and an electrodes were found rough and with white foreign material underneath.A fourier transforms infrared spectroscopy (ft-ir) was performed in order to identify the type of foreign material under the rings; the results demonstrated that particles were mainly composed of a styrene-butadiene material which is commonly used as a sealing and binding agent.The catheter outer diameters were measured and it was found within specifications.Further information received indicates that catheter damage might happen while getting the lasso out of the sheath too quickly; the instructions for use (ifu) indicate to avoid the usage of excessive force to advance or withdraw the catheter through the guiding sheath.Deflection and contraction tests were performed and the catheter passed the deflection test however failed contraction.Due to the lasso loop bent observed, contraction did not reach the minimum curve expected and there was no other internal failure that might have contributed to that condition.The device history record 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.Based on the available analysis finding results, the lasso bent and foreign particle found does not appear to be caused by any internal biosense webster, inc.Processes; since all the products are inspected to avoid visual damages and catheter outer diameters were found within specifications.

• Brand Name: LASSO® 2515 NAV ECO VARIABLE CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5792811
• MDR Text Key: 50392262
• Report Number: 9673241-2016-00431
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

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: 01/31/2019
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17407820L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1