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 Problems Break (1069); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2016

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) 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 an idiopathic ventricular tachycardia procedure with a thermocool smarttouch uni-directional navigation catheter and the deflection became stuck.While in the aorta, the deflection mechanism for the smarttouch catheter broke and would not un-deflect.The physician slowly pulled back on the catheter and removed it through the sr0 st.Jude medical 8.5f sheath.The catheter was then replaced and the procedure was continued.There was no patient consequence.There was no physical damage to the catheter.This event is mdr reportable because a stuck deflection can potentially be related to a serious injury.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 04/06/2016.(b)(4).It was reported that a patient underwent an idiopathic ventricular tachycardia procedure with a thermocool smarttouch uni-directional navigation catheter and the deflection became stuck upon receipt, the catheter was visually inspected and it was found in normal conditions.Then per the event reported a deflection test was performed and the catheter passed.Catheter was not stuck at any stage of the test; a normal behavior was observed.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 cannot be confirmed.Based on available analysis finding results, the failure mode do not appear to be caused by any internal bwi processes; since catheter pass all the functional tests.

• 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: 5494152
• MDR Text Key: 40389240
• Report Number: 9673241-2016-00188
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

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: 11/30/2016
• Device Model Number: D-1336-01-S
• Device Catalogue Number: D133601
• Device Lot Number: 17377757M
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2015
• 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