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

Model Number D-1237-02-S

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2016

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 ablation procedure with a lasso catheter and the contraction became stuck.From the beginning of the procedure, the mechanism to open the loop of the lasso did not function properly as it was impossible to reduce the diameter of the lasso.The button was pushed however the catheter was not responding.There was no ring or other physical damage observed at the distal end of the catheter.There was no difficulty experienced while maneuvering the catheter or during the withdrawal of the catheter through the st.Jude 8f swartz slo sheath.The catheter was changed and the procedure was completed with no patient consequence.This event has been assessed as mdr reportable because if the catheter loop is stuck/jammed in the contracted position, then this can potentially cause patient injury.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure with a lasso catheter and the contraction became stuck.From the beginning of the procedure, the mechanism to open the loop of the lasso did not function properly as it was impossible to reduce the diameter of the lasso.The button was pushed however the catheter was not responding.Upon receipt, the catheter was visually inspected and it was found in normal conditions.Then per the event, a deflection and contraction tests were performed and the catheter passed.Catheter was found within specifications.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
• Type of Device: CATHETER, 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: 5831891
• MDR Text Key: 52071684
• Report Number: 9673241-2016-00459
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K031161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/04/2016

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: 03/31/2019
• Device Model Number: D-1237-02-S
• Device Catalogue Number: D7L102515RT
• Device Lot Number: 17442281L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2016
• Initial Date FDA Received: 07/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1