MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE); CATHETER, ELECTRODE RECORDING

Model Number NAVIGATIONAL CABLES

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

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

Event Date 06/16/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure involving biosense webster navigational cables (model number and lot number unknown), and a noise device malfunction occurred.During the case, the physician discovered that there was signal noise on all available channels, including the 12 leads of body surface (bs) and all intracardiac (ic) signals.Noise was visualized on both the carto mapping system and the ep recording system at the same time, which made it very hard to proceed with the case, according to the physician.The physician had no available ekg or intracardiac signals available to monitor the patient¿s heart rhythm.While trouble-shooting the issue, the catheters were replaced, but it was determined by the physician that the cables were the causative device.There was no patient consequence.The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because the device was disposed of and no lot number was provided by the customer.Concomitant products: 1.Lasso 2515 nav vari, model# d-1290-01-s, lot# unk; 2.Ez steer thermocool navigation, model# d-1292-01-s, lot# unk.3.Carto 3, model# and lot# unknown.(b)(4).

• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: 3934821
• MDR Text Key: 4573300
• Report Number: 2029046-2014-00196
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P010068/S2
• 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
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NAVIGATIONAL CABLES
• Device Catalogue Number: NAVIGATIONAL CABLES
• Device Lot Number: UNKNOWN_NAVIGATIONAL CABLES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1