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

Model Number D-1343-01-S

Device Problem Difficult To Position (1467)

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

Event Date 08/18/2014

Event Type  malfunction  

Event Description

It was reported during an atrial fibrillation (afib) procedure, the catheter stopped deflecting during the case.The catheter was exchanged and the case was completed without any patient consequence.Upon receiving the product in biosense webster lab on (b)(4) 2014, it was noticed that ring # 1 dented proximal end, rings # 2, 6, 7 and #13 sharp edges, making this event reportable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4) was reported that the catheter stopped deflecting during the case.Upon receipt, the catheter was visually inspected and it was noticed that rings 1 was dented and rings 2, 6, 7 and 13 were sharp.These rings conditions were not originally reported on the complaint.It is unknown how the rings were damaged.Capa-(b)(4) has been created to investigate this condition.The catheter outer diameters were measured and the device was found within specifications then per the reported event, the catheter was tested for deflection and contraction and the catheter failed deflection.Afterwards, the catheter was dissected and it was noticed that the t bar slid down from its place.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 damage rings from leaving the facility.The reported customer complaint cannot be confirmed.In addition, a corrective action has been opened to address and resolve this issue.

• Brand Name: LASSO® 2515 NAV ECO VARIABLE 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: 4146523
• MDR Text Key: 21315045
• Report Number: 9673241-2014-00397
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 15951981L
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1