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 Signal Artifact/Noise (1036); Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2013

Event Type  malfunction  

Event Description

During a procedure, it was reported that there was noise in all catheters when connected, thermocool sf nav bi-directional catheter and lasso 2515 nav variable catheter.The procedure was completed with another catheter.There were no patient consequences.On (b)(6), received additional information requested from bwi representative that the noise was observed in all channels, body surface and intracardiac signals, were completely unreadable in both systems simultaneously.The physician was not capable to interpret both signals while these catheters were connected and required to disconnect them.After replacing both catheters, the noise did not return.Due to this additional information, the event became reportable.Awareness date changed from december (b)(6) 2013.

Manufacturer Narrative

(b)(4) are related to the same event.(b)(4).

Manufacturer Narrative

(b)(4).During a procedure, it was reported that there was noise in all catheters when connected, thermocool® sf nav bi-directional catheter and lasso® 2515 nav variable catheter.The procedure was completed with another catheter.There were no patient consequences.On december 23rd, received additional information requested from bwi representative that the noise was observed in all channels, body surface and intracardiac signals, were completely unreadable in both systems simultaneously.The physician was not capable to interpret both signals while these catheters were connected and required to disconnect them.After replacing both catheters, the noise did not returned.The returned device was visually inspected upon receipt and found in good physical condition.Per the 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.The customer complaint was not confirmed.

Manufacturer Narrative

Multiple attempts have been made to request for the complaint product to be returned for analysis.Product was not returned for investigation as initially reported.(b)(4).

• 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: 3583794
• MDR Text Key: 4031636
• Report Number: 2029046-2014-00014
• 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,Followup
• Report Date: 12/18/2013

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2013
• Initial Date FDA Received: 01/21/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/11/2014; 07/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1