MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) SMART TOUCH UNIDIRECTIONAL

Model Number D-1336-02-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 01/22/2014

Event Type  Injury  

Event Description

It was reported that during an afib procedure, before any ablation was performed, while mapping the left atrium with the ablation catheter, the patient¿s arterial pressure started to drop.A tamponade was verified by transesophageal echocardiogram.All products were easily removed from the patient and a pericardial drain was put in place but was not sufficient to solve the tamponade.The patient had to be transferred to the operation room.Once removed all products from the patient, the catheter was not reinserted in the patient.The emergency surgery was completed successfully.According the physician and also performing the procedure, the prognosis is good and the patient is doing well.There is no impairment of anybody function.The patient baseline health status was good and no major chronic diseases were verified.

Manufacturer Narrative

The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to [thermocool sf nav] approved under [p030031/s034].The concomitant products: ismus model # d-1171-27-s, lot # unknown.Lasso variable model # d-1237-02-s, lot # unknown.Preface sheath model # 301803m, lot # unknown.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that during an afib procedure, before any ablation was performed, while mapping the left atrium with the ablation catheter, the patient¿s arterial pressure started to drop.A tamponade was verified by transesophageal echocardiogram.All products were easily removed from the patient and a pericardial drain was put in place but was not sufficient to solve the tamponade.The patient had to be transferred to the operation room.Once removed all products from the patient, the catheter was not reinserted in the patient.The emergency surgery was completed successfully.The returned device was visually inspected upon receipt and it was found in normal conditions.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.Furthermore, an irrigation test was performed and the catheter passed, no occlusion was observed.The catheter was also evaluated for screening test and carto 3 and catheter passed.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Finally, a deflection test was performed and the catheter passed.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 pericardial effusion remains unknown.The ifu states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.

• Brand Name: SMART TOUCH UNIDIRECTIONAL
• 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: 3628830
• MDR Text Key: 21735692
• Report Number: 9673241-2014-00051
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-1336-02-S
• Device Catalogue Number: D133602
• Device Lot Number: UNK_D-1336-02-S
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2014
• Initial Date FDA Received: 02/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 64