MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO NAV DUO LOOP ECO CATHETER; ELECTRODE RECORDING CATHETER

Model Number D-1354-01-S

Device Problems Break (1069); Material Frayed (1262); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso nav duo loop eco catheter and resistance between the sheath and damage at the tip occurred.It was reported that when removing this catheter from an 8.5 french sl1 (st.Jude) sheath, a portion of the looped tip area was found to have been frayed and the wires around the electrodes were exposed.There did not appear to be any missing parts to the catheter and there was no patient injury observed.The case was completed.Upon request, additional information was provided on the event.Resistance was felt when withdrawing the catheter from the sheath.The damage reported on the spine cover of the double loop lasso is a reportable event because this could potentially cause serious injury to the patient.On (b)(6) 2015, biosense webster inc has decided to perform a remedial action on this product due to the damage observed on the spine cover of the double loop lasso.

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).Contact office and manufacturing site should reflect: (b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso nav duo loop eco catheter and resistance between the sheath and damage at the tip occurred.It was noticed that the lasso was frayed and the wires around the electrodes were exposed.There did not appear to be any missing parts to the catheter and there was no patient injury observed.Upon receiving, it was found that the spine cover was torn with internal wires exposed about 3.5 mm from the proximal side of ring 19.Additionally, between rings 12 and 17 the spine cover was ruptured and scrunched like an accordion.Furthermore, rings 5, 18 and 20 were squashed.Due to this returned catheter conditions, the outer diameters were measured and device was found within specifications.Additionally, a scanning electron microscope analysis was carried out over the damaged area and the results showed that the distal section of the rupture presented evidence of elongations.Exposed wires presented evidence of ductile dimples and the pattern suggests that the wires were separated due to an application of tension until separation.The distal section (area between rings 12 and 17) presented an accordion condition.This could be probably related to the tension applied on the body with the unknown object.This issue is further investigated under an internal corrective action.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.All the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.The customer complaint has been verified.

Manufacturer Narrative

This supplemental report is in response to an fda letter received by bwi, dated march 27, 2015 regarding report number: 9673241-2015-00122.Please confirm or provide the model, lot, serial, and/or catalog number(s) of the device listed in the medical device report as applicable.Response: the device listed in the medical device report is the lasso nav duo loop eco catheter: model# d-1354-01-s, lot# 16093028l, catalog# d135401.Please provide any evaluation of the event described in the medical device report by the attending physician, surgeon, hospital representative or health care professional.Response: during the investigation, the bwi medical safety officer followed up with the attending physician regarding this complaint.The attending physician provided a procedural narrative of the event.He stated that he felt resistance upon attempting to withdraw the duo loop lasso catheter into the sheath.On fluoroscopy, there were no abnormalities noted so he applied some additional force, which he deemed was not excessive based on his experience.When the catheter could not be removed, he visualized the catheter on fluoroscopy and noticed the catheter did not appear normal.He removed the catheter with the sheath en bloc and after removal from the patient, noticed the plastic covering was broken with exposed wires.The physician stated that there was no harm that came to the patient and the procedure was not prolonged since this occurred at the end of the case.Please provide any evaluation of other information used by your firm to determine whether the events described in the medical device report are or are not attributable to the device.Response: in this complaint it was reported that there was difficulty to retract the catheter through the sheath using the st jude fast cath 8.5 french sl1 non-soft tip (hard tip).Upon visual inspection the catheter revealed a torn spine cover and "accordion" shape along the length of the nitinol upon retrieval.Our investigation revealed that sheath compatibility is likely the issue.During the original design verification test (dvt) of this product it was reported that in the sheath compatibility testing for duo loop ((b)(4)) failures had been observed when using the st jude fast cath sr0 (hard tip) sheath.The dvt passed when the st jude fast cath sr0 (hard tip) was switched to the bwi preface (soft tip sheath).User manual (ifu) has indicated that soft tip sheaths should be used with this catheter.We could not duplicate the exact failure mode observed in the field using the catheter following ifu instructions.In order to reproduce the failure and to achieve a spine cover tear and accordion shape we had to administer the catheter to non-clinical relevant situation; by pinching the sheath tightly with a clamp.Please provide a complete list of all related medical device reporting (mdr) access numbers, as well as the reason for their inclusion in the trend.Response: in addition to this corresponding mdr (9673241-2015-00122), there has been one other identical event with the same failure mode for this functional family, duo loop lasso.These events have been reported as malfunctions.The report number for this second event is listed below.The 9673241-2014-00529/malfunction/(b)(4) the second complaint was received on (b)(6) 2014 and reported difficulty to retract the catheter through the sheath.In addition, the catheter revealed a torn spine cover and "accordion" shape along the length of the nitinol upon retrieval.Please discuss any actions taken to address this or other similar complaints.Response: the lasso nav duo loop eco catheter family had two complaints with the identical failure mode reported during (b)(6) 2014 ¿ (b)(6) 2015.Members of the biosense webster quality review board agreed to open an internal corrective action and the following actions which are in progress: initiated a field action to recall (z-1242-2015) all units in the field.Bwi presented risk benefit analysis to management board and decided to discontinue the production of the lasso nav duo loop eco catheter.If you have any questions regarding the response provided please do not hesitate to contact us.(b)(4).

• Brand Name: LASSO NAV DUO LOOP ECO CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER
• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4541662
• MDR Text Key: 15118672
• Report Number: 9673241-2015-00122
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2015

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: 02/27/2015
• Device Model Number: D-1354-01-S
• Device Catalogue Number: D135401
• Device Lot Number: 16093028L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 02/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/08/2015; 05/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2014
• 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