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 Device Inoperable (1663); Noise, Audible (3273)

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

Event Date 07/01/2014

Event Type  malfunction  

Event Description

It was reported that a patient, underwent a procedure with a lasso® nav eco variable catheter and noise signal device malfunction occurred.The noise occurred at the electrode 1-2 and 3-4 when the catheter was inserted into the patient¿s body.There was no patient consequence.The procedure was completed successfully with a similar-like device.This event was originally considered non-reportable, however, bwi became aware of physical damage (sharp edge) found on ring # 1 on the product returned condition from bwi failure analysis lab on july 17, 2014 and have reassessed the event as reportable.

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).

Manufacturer Narrative

(b)(4) it was reported that a patient, underwent a procedure with a lasso nav eco variable catheter and noise signal device malfunction occurred.The noise occurred at the electrode 1-2 and 3-4 when the catheter was inserted into the patient¿s body.There was no patient consequence.The procedure was completed successfully with a similar-like device.This event was originally considered non-reportable, however, bwi became aware of physical damage (sharp edge) found on ring # 1 on the product returned condition from bwi failure analysis lab on july 17, 2014.Upon receipt, the catheter was visually inspected and there was a wrinkle close to ring # 20.In addition, ring # 1 was damaged.The ring # 1 condition was not originally reported on the complaint.It is unknown how the ring was damaged.An internal corrective action has been created to investigate this condition.Due to this, the catheter outer diameters were measured and the device was within specifications per the reported event, the catheter was tested for electrical performance and it was found within specifications.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 damage rings from leaving the facility.The customer complaint was not confirmed.Management is notified of failure analysis results using monthly complaint trend reporting.For the damage ring, as previously stated, an internal corrective action has been created.

• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3967914
• MDR Text Key: 17164013
• Report Number: 9673241-2014-00285
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: UNKNOWN_D-1343-01-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2014
• 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