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 Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2015

Event Type  malfunction  

Manufacturer Narrative

A) 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.B) as lot # 17120368m 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).

Event Description

It was reported that a patient underwent a procedure with a thermocool smarttouch uni-directional navigation catheter and the catheter was delaminated while inside of the patient.During the case, a temperature sensor issue occurred that is non-indicative of an mdr reportable complaint.When the complaint catheter was removed from the patient, it was noticed that the catheter tip appeared to be damaged with inner structures visible.The procedure was completed without patient consequence by replacing the catheter.Additional investigation was performed to clarify the event reported; however, no relevant information was provided.This event is being reported because internal components are exposed to the patient which increases the potential risk of thrombus formation.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a thermocool® smarttouch® uni-directional navigation catheter and the catheter was delaminated while inside of the patient.During the case, a temperature sensor issue occurred that is non-indicative of an mdr reportable complaint.When the complaint catheter was removed from the patient, it was noticed that the catheter tip appeared to be damaged with inner structures visible.The procedure was completed without patient consequence by replacing the catheter.Additional investigation was performed to clarify the event reported; however, no relevant information was provided.This event is being reported because internal components are exposed to the patient which increases the potential risk of thrombus formation.The bwi failure analysis lab received the device for evaluation.Upon receipt, the catheter was visually inspected and it looks in normal condition, no delamination or exposed wires were observed.The catheter tip didn't show any damage.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.The device history record (dhr) was reviewed.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has not been verified.

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.(b)(4).

• 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: shahe garabedian ; 9098397362
• MDR Report Key: 4917274
• MDR Text Key: 22397338
• Report Number: 9673241-2015-00445
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-1336-01-S
• Device Catalogue Number: D133601
• Device Lot Number: UNK_D-1336-01-S
• Other Device ID Number: (01)10846835008982
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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