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); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.As lot # 17218705l was provided, the device history record(s) 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.Methods: no testing methods performed.Results: no results available since no evaluation performed.Conclusion: device not returned.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a lasso 2515 nav eco variable catheter and the loop of the catheter stopped contracting, which is not indicative of an mdr reportable event.The issue was resolved by replacing the catheter with a similar device.The procedure was completed without patient consequence.Additional information was requested to clarify the event and it was informed that the loop had an abnormal sharp angle at the distal part with no wires exposed, there was no difficulty experienced to remove the catheter since the loop was able to relax.This event is being reported because a sharp angle possesses a significant risk to damage the vascular structures of the patient even if the integrity of the catheter is intact.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 03/22/2016.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a lasso® 2515 nav eco variable catheter and the loop of the catheter stopped contracting and the loop had an abnormal sharp angle at the distal part with no wires exposed, there was no difficulty experienced to remove the catheter since the loop was able to relax.Upon receipt, the catheter was visually inspected and it was found in normal conditions.Then per the event, deflection and contraction tests were performed and the catheter passed.No sharp angle or any other abnormal characteristic was found.There was no issue observed during the test.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.The customer complaint cannot be confirmed.

• 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: shahe garabedian ; 9098397362
• MDR Report Key: 5080778
• MDR Text Key: 26530253
• Report Number: 9673241-2015-00636
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 08/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17218705L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2015
• 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