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 Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2015

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.Concomitant products were used during this study: carto 3 mapping system.(b)(4).The device was not returned to bwi.

Event Description

It was reported that a patient underwent a radiofrequency ablation for atrial fibrillation.The electrical potentials were not displayed on both carto mapping system and recording system when lasso 2515 nav eco catheter was inserted into the patient¿s cardiac cavity.The issue was not resolved by changing the cable.The issue was resolved by changing the catheter.The procedure was completed without patient¿s consequence.It¿s unknown whether there was other ecg/ekg signal available for physician to monitor the patient¿s heart rhythm (such as defibrillator, anesthesia monitor, etc.).Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Bwi takes conservative approach to report this event.

Manufacturer Narrative

The device history record (dhr) for the lot number 17258933l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 12/02/15.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 Narrative

(b)(4).It was reported that the electrical potentials was not displayed on both the carto system and the lab when the lasso 2515 nav eco catheter 20 p was inserted into the cardiac cavity.The cable was changed but the issue continued.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.The complaint product(s) will be returned for analysis.Upon receipt, the catheter was visually inspected and it was found in normal conditions.The returned device was then evaluated for electrical resistance and current leakage and it failed on electrodes # 15 and #20.Further examination revealed that the lead wires # 15 and #20 were broken causing the improper signal condition.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.The customer complaint has been verified.The root cause of the wire breakage cannot be determined.

• 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 ; 9497893837
• MDR Report Key: 5189895
• MDR Text Key: 30344080
• Report Number: 9673241-2015-00787
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/02/2015

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: 05/31/2018
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17258933L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/01/2015
• Initial Date FDA Received: 10/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/06/2015; 12/22/2015; 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1