MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) LASSO? ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1220-39-S

Device Problem Defective Component (2292)

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

Event Date 10/24/2013

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, there was an electrical malfunction of the lasso catheter.Visualized defective contact of electrodes 8, 9 and 10.After replacing the catheter-cable, the problem was not resolved.The catheter was replaced with another one from the same type and the procedure was successfully completed.There was no patient consequences.The complaint reported was not indicative of a reportable event.Upon visual inspection of the returned complaint catheter on (b)(6) 2013 by the bwi failure analysis lab, they noted char on electrode ring #3 which the length measured more than 1mm.This condition was not reported by the customer.The presence of the char on the catheter is indicative of a reportable event, thus marking (b)(6) 2013 as the awareness date for this report.

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.The reported lot number is 15873008l.(b)(4).

• Brand Name: LASSO? ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, 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: 3575335
• MDR Text Key: 4062784
• Report Number: 2029046-2014-00012
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K002333
• 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: 11/11/2013

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-1220-39-S
• Device Catalogue Number: D7L1020RT
• Device Lot Number: UNKNOWN_D-1220-39-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2013
• Initial Date FDA Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: No
• 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