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

Model Number D-1312-09-S

Device Problems Break (1069); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2013

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, the acquire button grayed out and they could not fam or take points with the lasso nav catheter.Also, error 401 appeared on the workstation.It was also noted that when switching to the ablation catheter, the error disappeared and they could take points and fam.Changing the reprocessed cable from the lasso nav to the piu resolved the issue.The case was completed without any patient consequence.On (b)(6) 2013, upon receiving the product in (b)(4), it was noticed that pu in the anchor window is damaged and rough making this event reportable.

Manufacturer Narrative

(b)(4).

• Brand Name: LASSO® NAV 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: 3572752
• MDR Text Key: 4036969
• Report Number: 9673241-2014-00013
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2013

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 Expiration Date: 06/30/2012
• Device Model Number: D-1312-09-S
• Device Catalogue Number: D131209S
• Device Lot Number: 15429176L
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2013
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2011
• Type of Device Usage: Initial
• Patient Sequence Number: 1