MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) LASSO 2515 NAV VARIABLE CATHETER; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number D-1290-01-S

Device Problems Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2014

Event Type  malfunction  

Event Description

Originally, the customer reported to bwi that they experienced a deflection issue during a pre-op procedure with a lasso 2515 nav variable catheter.The procedure was completed successfully with no patient consequence using a similar-like device, but the suspect device was not returned to bwi and the event was deemed non-reportable based on the available information.However, the awareness date was updated, due to recent product return and findings from the bwi failure analysis lab, from april 25, 2014 to june 10, 2014.The lab found foreign light blue material on the catheter, and discovered that one of the catheter¿s rings contained a sharp edge.The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.

Manufacturer Narrative

When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.Concomitant products: unk.(b)(4).Lot# 15990148l.

Manufacturer Narrative

(b)(4) originally, the customer reported to bwi that they experienced a deflection issue during a pre-op procedure with two lasso 2515 nav variable catheters.The bwi failure analysis lab received both complaint devices for evaluation.Upon receipt of the first catheter, the catheter was visually inspected and it was found that ring #20 and #19 were damaged, they contained dents and a sharp edge.Additionally, the catheter had an unidentifiable light blue foreign material under ring #19.It is unknown what caused these catheter conditions, all bwi catheters are inspected for visual damages before packaging.On line inspections are in place to prevent damaged rings from leaving the facility.Then, per the reported event, the catheter was tested for deflection and contraction and the catheter failed deflection.Due to the failure, the catheter was dissected and it was noticed that the t-bar was folded.The reported customer complaint has been verified with the first complaint catheter.Internal corrective actions have been opened to investigate the t-bar issue and the damaged ring/foreign material issue.The second complaint catheter was also analyzed.Upon receipt, the catheter was visually inspected and it was found in normal conditions.Per the reported event, a deflection and contraction tests were performed and the catheter passed both.The customer complaint cannot be confirmed with the second complaint catheter.For both complaint devices, 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.

• Brand Name: LASSO 2515 NAV VARIABLE CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3910288
• MDR Text Key: 4580507
• Report Number: 2029046-2014-00186
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K081258
• 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: 04/29/2014

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-1290-01-S
• Device Catalogue Number: LN222515CT
• Device Lot Number: UNKNOWN_D-1290-01-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2014
• Initial Date FDA Received: 07/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2013
• 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