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

Model Number D-1336-01-S

Device Problem Break (1069)

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

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) for the lot number 17214255m has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes (evaluation codes) will be added to until the biosense webster system is also updated.Evaluation codes: methods codes: no testing methods performed.Results codes:no results available since no evaluation performed.Conclusion codes: device not returned.(b)(6).(b)(4).

Event Description

It was reported that during a procedure with a smart touch unidirectional catheter when pre-forming the extremity of the catheter, the pebax broke.This issue occurred before using the product on the patient.The procedure was completed with another like device.There was no patient consequence.Follow-up has been made to obtain clarification to this complaint.However, no further clarification has been made available.Therefore, since clarification was not received on the integrity of the catheter, we will take the conservative approach and report this event as a reportable malfunction.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 3/29/2016.During the visual inspection, the pebax looked normal and did not appear to have any damage.However, the shaft was found to be cracked open 9.5cm proximal of tip.Therefore, clarification was requested.It was clarified that the damage observed by the customer was at the shaft area.(b)(4).It was reported that during a procedure with a smart touch unidirectional catheter when pre-forming the extremity of the catheter, the pebax broke.This issue occurred before using the product on the patient.The procedure was completed with another like device.There was no patient consequence.Upon receipt, the device was visually inspected and the pebax was found in good condition; no damage was observed at the area.Further information received clarified that the damage observed by the customer was at the shaft area.Continuing with the visual inspection, the shaft was found cracked open.According to the information received in the complaint, a pre-shape of the extremity of the catheter was performed before the procedure.This action might have contributed to the shaft damage since the instructions for use (ifu) indicates to avoid to manually pre-shaping the distal shaft of the catheter.An internal corrective action has been opened to address the thermocool smart touch broken shaft issue.The device was then evaluated for electrical resistance and thermocouple test and the catheter failed; current leakage was observed on all electrodes.The catheter shaft condition might have contributed to the device failure.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 regarding a shaft damage has been verified.Based on available analysis finding results, the failure mode does not appear to be caused by any internal biosense webster inc.Processes.The root cause of the shaft condition might be due to the pre-shape performed.An internal corrective action has been opened to address the thermocool smart touch broken shaft issue.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-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: 5475654
• MDR Text Key: 39806371
• Report Number: 9673241-2016-00149
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

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: 03/31/2016
• Device Model Number: D-1336-01-S
• Device Catalogue Number: D133601
• Device Lot Number: 17214255M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2016
• Initial Date FDA Received: 03/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2015
• 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