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 Problems Bent (1059); Entrapment of Device (1212); Sticking (1597); Positioning Problem (3009); Torn Material (3024)

Patient Problem Physical Entrapment (2327)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, the lasso nav catheter got hung up on the sheath when the physician was pulling it out of the left atrium.The physician had to pull extremely hard to get the catheter to come through the sheath.When the catheter was removed, one electrode was bent about half a millimeter.The case resumed without any patient consequence.Upon receiving the product in biosense webster lab, it was noticed that ring #1 torn, sharp sticking off ring about 1.8 cm, making this event reportable.Investigation is still in progress.A supplemental report on device evaluation will be submitted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).It was reported that the lasso nav catheter got hung up on the sheath when the physician was pulling it out of the la.The physician had to pull extremely hard to get the catheter to come through the sheath.When the catheter was removed one electrode was bent about half a millimeter.Upon receipt, the catheter was visually inspected and it was found that ring 1 was damaged.In addition, a corrective action has been opened to address and resolve this issue.The catheter ods were measured and it was found within specifications.Therefore, it remains unknown the origin of the catheter hanging.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 this type of damage/defect from leaving the facility.The reported customer complaint has been verified.However, it remains unknown how the issue occurred.

• 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: 3854423
• MDR Text Key: 4616964
• Report Number: 9673241-2014-00217
• 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: 05/12/2014

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-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: UNKNOWN_D-1343-01-S
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 06/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1