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 Problems Material Integrity Problem (2978); Physical Property Issue (3008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 12/29/15.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.The device history record (dhr) has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).

Event Description

This complaint is originally created for an mdr non-reportable issues.It was reported that a smarttouch thermocool catheter could not curve adequately.The issue was resolved by changing the catheter.The procedure was completed successfully without patient's consequence.This complaint was re-assessed to mdr reportable per bwi failure analysis lab findings about bumps in two areas in tip lumen on (b)(6) 2015.The first one about 5.8mm has metal exposed.Second one has a bump about 6.3mm from the transition with peek housing with no metal is exposed.This event is mdr reportable as exposed wire compromised the integrity of the catheter and posed risk to patient due to the potential of thrombus.The awareness date of this complaint is reset to 12/29/2015 based on lab findings on (b)(6) 2015.

Manufacturer Narrative

(b)(4).Device evaluation of catheter lot #17268664m: the returned device was visually inspected upon receipt and tip lumen had bumps.Per these condition and event reported an x-ray of the catheter was taken and it was noticed that one of the t bar¿s was slid down.This condition might contribute to the bumps observed due to the fact that the t-bar applied stress at that tip lumen area while sliding down.A corrective action was opened for the t bar issue.A deflection test was performed and catheter failed due to the t-bar out of place.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 has been verified.Based on available analysis results, complaint appears to be caused by internal bwi processes,specifically the manufacturing process; therefore a corrective action has been opened to further address this issue.

• 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: joaquin kurz ; 9497893837
• MDR Report Key: 5375450
• MDR Text Key: 36741157
• Report Number: 9673241-2016-00039
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• 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: 11/03/2015

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: 06/30/2016
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17268664M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 01/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1