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

Model Number D-1343-02-S

Device Problems Break (1069); Material Protrusion/Extrusion (2979); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a lasso® 2515 nav eco variable catheter and electrodes became damaged.The electrodes on the catheter were protruding on the edges and were not a smooth finish for moving in and out of the sheath.There were no wires exposed or difficulty removing the catheter.The catheter was replaced and the issue was resolved.The procedure was continued and completed with no patient consequence.This event is mdr reportable because the electrode damage may cause damage to vascular endothelial linings during the withdrawal of the catheter.

• 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6361271
• MDR Text Key: 68831653
• Report Number: 9673241-2017-00157
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• 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
• Report Date: 02/02/2017

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: 10/31/2019
• Device Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: 17604735L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2016
• 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