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

Model Number D-1220-79-S

Device Problems Device Operates Differently Than Expected (2913); Material Twisted/Bent (2981); Torn Material (3024)

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

Event Date 08/21/2014

Event Type  malfunction  

Event Description

It was reported that a patient, underwent an atrial fibrillation procedure with a lasso¿ electrophysiology catheter with auto id and stopped deflecting as intended.The catheter was replaced with a same type of product and lot number as the previous one, deflection issue failed to perform as expected.The procedure was completed successfully with a similar-like device.This event is being reported because the bwi failure analysis lab received the device for evaluation and found damage in one of the two products returned: spine cover is twisted and torn (internal wires are exposed).This finding is reportable because the potential risk that might lead to the patient.The awareness date for this record is september 3rd because the product was returned and received under this condition.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that a patient, underwent an atrial fibrillation procedure with a lasso electrophysiology catheter with auto id and stopped deflecting as intended.The catheter was replaced with a same type of product and lot number as the previous one, deflection issue failed to perform as expected.The procedure was completed successfully with a similar-like device.This event is being reported because the bwi failure analysis lab received the device for evaluation and found damage in one of the two products returned: spine cover is twisted and torn (internal wires are exposed).This finding is reportable because the potential risk that might lead to the patient.The awareness date for this record is september 3rd because the product was returned and received under this condition.A further investigation was performed on this finding, it was reassessed and determined that the overall health risk to the patient is low as the most likely harm is an intra-procedural delay.If unrecognized by the user, it can lead to more serious complications like valvular damage, and puncture of the myocardium.However the likelihood of serious injury is low.The bwi failure analysis lab received the devices for evaluation.The returned device a was visually inspected upon receipt and it was found spine cover was twisted and torn leaving internal wires and tubes exposed.Further information received indicates that the physician did not note that the spin cover was broken prior to insertion of the catheter in the body on both catheters used during the procedure.A dissection of the catheter was made and it was noticed that the lasso loop was internally loose from the nitinol/polymide assembly causing the movement on its own axis.Pu residues were not found in the area.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 device b was visually inspected and it was found in normal conditions.Then per the reported event, a deflection test was performed and the catheter passed.The customer complaint was confirmed.Management is notified of failure analysis through the monthly trending meeting.An internal corrective action has been created to address the spinning lasso.

• Brand Name: LASSO¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID
• 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: 4139796
• MDR Text Key: 4912236
• Report Number: 9673241-2014-00380
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002333
• 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: 08/21/2014

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 Expiration Date: 03/31/2017
• Device Model Number: D-1220-79-S
• Device Catalogue Number: D7L1020CT
• Device Lot Number: 16103936L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 10/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• 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