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

Model Number D-1354-05-S

Device Problems Detachment Of Device Component (1104); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a lasso nav duo loop eco catheter and at the end of the procedure there was difficulty retracting the lasso catheter from the sl1 sheath, therefore it was removed from patient.Upon removal it was noted that the catheter coating detached exposing wires with no missing pieces.The procedure was completed without any patient consequence.This complaint is reportable because inner components are exposed and there is a higher risk that this could potentially contribute to a death or serious injury.

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.Non-bwi product used: sl1 8.5 fr sheath (st.Jude medical).(b)(4).

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an atrial fibrillation procedure with a lasso nav duo loop eco catheter and at the end of the procedure there was difficulty retracting the lasso catheter from the sl1 sheath, therefore it was removed from patient.Upon removal it was noted that the catheter coating detached exposing wires with no missing pieces.This complaint is reportable because inner components are exposed and there is a higher risk that this could potentially contribute to a death or serious injury.The bwi failure analysis lab received the device for evaluation.Upon receiving, it was found that the spine cover was ruptured and scrunched towards the catheter¿s tip.A white material was also found stuck underneath electrical ring #18 at the proximal end.Upon investigation, the white material was determined to come from the sheath used.Additionally, a scanning electron microscope analysis was carried out and the results showed that the distal section of the rupture presented evidence of elongations.Proximal section of the rupture presented evidence of physical damages, elongations and accordion condition.These conditions suggest that the device was induced to an excessive application of tension with the sheath on the rupture area.The accordion condition also suggests that the tension applied to the device was on the direction to the distal tip.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.An internal corrective action has been opened to address the accordion condition for the lasso nav duo loop eco family.

• 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 ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4283025
• MDR Text Key: 5224589
• Report Number: 9673241-2014-00529
• 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
• Report Date: 11/03/2014

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 Model Number: D-1354-05-S
• Device Catalogue Number: D135405
• Device Lot Number: UNKNOWN_D-1354-05-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2014
• Initial Date FDA Received: 11/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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