MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1260-02-S

Device Problems Difficult To Position (1467); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 10/28/2015

Event Type  Injury  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.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.Concomitant medical products: stockert 70 system (model# m-5463-01 serial# (b)(4)) carto 3 system (model# m-4800-01 serial# (b)(4)).(b)(4).

Event Description

It was reported that a female patient in her 70's underwent an idiopathic ventricular tachycardia procedure with an ez steer nav ds bi-directional electrophysiology catheter and suffered a cardiac perforation.It is reported that while mapping the right ventricular outflow tract (rvot) the physician had trouble moving and there was a perforation as the mapping catheter appeared to be outside of the endocardium.There was no patient intervention and no ablations had been performed.On echocardiogram there was no noticeable pericardial effusion.The patient was under conscious sedation and did not move.There were no error messages observed on biosense webster equipment during the procedure.The case was cancelled.Additional information was received on the event.The patient was given anticoagulation during the procedure which was maintained at less than 250s.No transseptal puncture was performed.The patient had no medical history that may have contributed to the event.There were no changes in the patient's vitals other than visually seeing the catheter outside of the right side.The patient did not require hospitalization or medical intervention due to the event.The physician's opinion regarding the cause of this adverse event is that he pressed through right atrial appendage thinking he was in the rvot.There was no product problem.

Manufacturer Narrative

(b)(4) it was reported that a female patient in her 70¿s underwent an idiopathic ventricular tachycardia procedure with an ez steer nav ds bi-directional electrophysiology catheter and suffered a cardiac perforation.The returned device was visually inspected upon receipt and it was found in normal conditions.Per the event reported, a deflection test was performed and the catheter passed.The catheter was also evaluated for eeprom, carto 3 and sensor functionality.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was tested for electrical performance, temperature response and stockert compatibility and it 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 catheter passed all specifications.The root cause of the cardiac perforation remains unknown.The ifu states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.The root cause does not appear to be manufactured related.

• Brand Name: EZ STEER¿ NAV DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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 ; 9497893837
• MDR Report Key: 5228132
• MDR Text Key: 31332996
• Report Number: 9673241-2015-00824
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010068/S6
• 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: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: D-1260-02-S
• Device Catalogue Number: BN7TCFF8L
• Device Lot Number: 17027501M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2014
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 70 YR
• Patient Weight: 54