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

Model Number D-1327-01-S

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2015

Event Type  malfunction  

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.As lot # 17156533m was provided, the device history record(s) 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).(b)(6).(b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool smarttouch bi-directional navigation catheter and deflection issue towards one curve was experienced, which is not indicative of an mdr reportable event.Catheter replacement was required to complete the procedure without patient consequence.On (b)(6) 2015, bwi failure analysis lab received the device for evaluation and found a bump on the lumen shaft that exposed metal at about 2.5cm from peek housing transition.This finding is reportable because metal exposed increases the risk to the patient of thrombus formation from exposure of internal parts.

Manufacturer Narrative

The fda shut down their emdr server along august 6th ¿ august 10th for maintenance and the 3500a codes were updated.While the bwi complaints system is updated, the mapping will be done manually.(b)(4) it was reported that a patient underwent a procedure with a thermocool® smarttouch® bi-directional navigation catheter and deflection issue towards one curve was experienced, which is not indicative of an mdr reportable event.Catheter replacement was required to complete the procedure without patient consequence.On july 9th 2015, bwi failure analysis lab received the device for evaluation and found a bump on the lumen shaft that exposed metal at about 2.5cm from peek housing transition.This finding is reportable because metal exposed increases the risk to the patient of thrombus formation from exposure of internal parts.Further information received stated that physical damage of the catheter was not noticed by the costumer.The bwi failure analysis lab received the device for evaluation.Upon receiving, a deflection test was performed and catheter failed; during an x-ray analysis it was determined that the t-bar slid down and crossed the catheter lumen due to the stress applied at tip section.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 was confirmed.An internal corrective action has been opened to address t bar issues.

• 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 32599 ; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4942921
• MDR Text Key: 23149146
• Report Number: 9673241-2015-00481
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 05/27/2015

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: 12/31/2015
• Device Model Number: D-1327-01-S
• Device Catalogue Number: D132701
• Device Lot Number: 17156533M
• Other Device ID Number: (01)10846835009163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2015
• 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