MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1327-05-S

Device Problem Kinked (1339)

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Date 04/02/2015

Event Type  Injury  

Event Description

It was reported that during an idiopathic ventricular tachycardia procedure, while performing the transseptal puncture, the patient suffered a perforation and pericardial effusion.There was a small baseline effusion present prior to procedure, and it grew to 1cm after perforation.A pulmonary artery catheter (swan-ganz catheter) was placed to monitor right atrium pressure and the patient was stable when sent to the icu for observation.The smarttouch catheter became kinked when removed from the patient.They exchanged the catheter to proceed with and completed the case.Since both ablation catheters were used inside the patient, bwi takes conservative approach and report both ablation catheters.Attempts have been made to obtain additional information but no response has been received at this time.No product malfunctions have been confirmed related to this patient injury.

Manufacturer Narrative

(b)(4).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).Bwi equipment in use: c3 system, (b)(4); stockert, sn unknown; coolflow pump, sn unknown; thermocool smarttouch catheter, d132705, lot # unknown; thermocool smarttouch catheter, d132705, lot # 17134619m.(b)(4).

Manufacturer Narrative

Upon receiving the product in biosense webster lab on april 26th 2015, it was noticed that shaft bent and broken about 11.4cm from client tip also broken braid wires and internal parts exposed.Investigation is still in progress.A supplemental report on device evaluation will be submitted.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that during an idiopathic vt case, while performing the transseptal puncture, the patient suffered a perforation and pericardial effusion.There was a small baseline effusion present prior to procedure, and it grew to 1cm after perforation.A swan-ganz catheter was placed to monitor ra pressure and the patient was stable when sent to the icu for observation.The smarttouch catheter became kinked and a break in the insulation was noticed when removed from the patient.They exchanged the catheter to proceed with and complete the case.Replacement requested.Upon receiving, the catheter was visually inspected and it was found the shaft was found broken at proximal section from the handle.The broken point present marks of stress.Further information received indicates that patient had an odd venus anatomy, this condition might contributed to the catheter damage however it cannot be conclusive determinate.In addition, a corrective action has been opened to address and resolve this issue.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 was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.Furthermore, an irrigation test and deflection test were performed and the catheter passed, no occlusion was observed.The catheter was tested for eeprom and sensor functionality and carto.The catheter failed during sensor functionality test and carto.Error 105 was displayed.Further examination showed the sensor within specifications.According to the calibration results and the sensor readings, the improper condition was attributed to an open circuit on the biosensor wire.The cause of the cardiac perforation cannot be determinated.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: shahe garabedian ; 9098397362
• MDR Report Key: 4726043
• MDR Text Key: 21539036
• Report Number: 9673241-2015-00235
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• 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,Followup
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17134619M
• Other Device ID Number: (01)10846835009200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening