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

Model Number D-1312-01-S

Device Problems Dent in Material (2526); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2014

Event Type  malfunction  

Event Description

A patient underwent a procedure with a lasso sas catheter and a sharp electrode ring issue occurred.It was reported that during the procedure, the catheter could not apperceive the magnetic signal.The catheter was exchanged.The procedure was completed without patient consequence.Upon visual inspection of the returned complaint catheter on (b)(6) 2014, the bwi failure analysis lab noted that the electrode ring #1 was dented and sharp on the proximal side.Multiple attempts have been made to obtain clarification to this returned catheter condition.However, no further information has been made available.The event was originally considered non reportable.However, the returned catheter condition noted on (b)(6) 2014 has been assessed as reportable.The awareness date was updated for this record from (b)(6) 2014 as when the issue was found from the bwi failure analysis lab.

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.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

(b)(4) it was reported that during the procedure, the catheter could not apperceive the magnetic signal.The catheter was exchanged.The procedure was completed without patient consequence.Upon receipt, the catheter was visually inspected and it was found that electrode ring 1 was dented and sharp on the proximal side.This condition was not originally reported on the complaint.It is unknown how the electrode ring was damaged.An internal corrective action has been opened to address this condition.The catheter outer diameters were measured and the catheter was found within specifications.Then per the reported event, the catheter was tested for eeprom, 4 khz and calibration functionality.The catheter failed during calibration functionality test and 4 khz.According to the calibration results and the 4 khz readings, the improper condition was attributed to a potential pc board failure.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 damaged electrode rings from leaving the facility.The reported customer complaint has been verified.For the damaged electrode ring, as previously stated, an internal corrective action has been opened to address this condition.Also an internal corrective action has been opened to address the potential pcb issues.

• Brand Name: LASSO® NAV 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: 4117347
• MDR Text Key: 4942178
• Report Number: 9673241-2014-00369
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093376
• 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: 08/12/2014

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 Expiration Date: 04/30/2015
• Device Model Number: D-1312-01-S
• Device Catalogue Number: DLN1215CT
• Device Lot Number: 17004972L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/12/2014
• Initial Date FDA Received: 09/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2014
• 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