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

Model Number D-1220-60-S

Device Problems Bent (1059); Sticking (1597); Physical Resistance (2578); Material Deformation (2976)

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

Event Date 05/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned device was visually inspected upon receipt and it was found in normal conditions.However, during a second visual inspection, ring #3 was found bent.The catheter outer diameters were measured and were found within specifications.During the manufacturing process, 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.Further clarification received indicates that resistance was noticed while manipulating the catheter, which may have contributed to the electrode.The instructions for use indicate to avoid the use of excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.In addition, extra care should be taken while inserting, aspirating and manipulating the guiding sheath.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 regarding an electrode deformation has been verified.Based on available analysis finding results, the failure mode does not appear to be caused by any internal bwi processes.

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a lasso catheter where resistance with the sheath and a physical deformation of the catheter was found.During the procedure, it was noted that catheter was stuck to the sheath, and it was found that there was a physical deformation of the second and third electrodes on the catheter.The catheter was changed out for another one, and the procedure was completed with no patient consequence.The damage to the catheter did not result in any wires being exposed, nor did any of the rings appear to be lifted or sharp.Upon return to biosense webster, the catheter was confirmed to have a bent third ring.If the catheter integrity is not maintained, this creates the possibility for sharp ring edges, which can present a risk to the patient.As a result, this event is mdr reportable.

Manufacturer Narrative

On 8/18/2016, biosense webster received additional information from the affiliate regarding the condition of the returned catheter: the catheter was not withdrawn with difficulty from the patient.The condition of the catheter was noticed prior to withdrawal from the patient/returning the catheter for analysis.It is confirmed that there was no patient consequence.(b)(4).

• Brand Name: LASSO¿ ELECTROPHYSIOLOGY 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: 5887477
• MDR Text Key: 53458997
• Report Number: 9673241-2016-00516
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: D-1220-60-S
• Device Catalogue Number: D7L2015RT
• Device Lot Number: 17387298L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2016
• 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