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 Cut In Material (2454); Device Displays Incorrect Message (2591); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ bi-directional navigation catheter and errors were being displayed.During procedure, catheter was connected and system showed error 106, 279 and data streaming.The catheter was replaced and resolved the issue.The procedure was completed without patient consequence.This event was originally considered non-reportable, however, bwi became aware of product was returned, clear sensor sleeve (pebax) is torn on the distal side of ring # 2 (cuts are next to the edge of ring) observed on (b)(6) 2015 and have reassessed the event as reportable.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on (b)(4) 2015.The analysis has begun but is not completed at this time.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent a procedure with a thermocool® smart touch¿ bi-directional navigation catheter and errors were being displayed.During procedure, catheter was connected and system showed error 106, 279 and data streaming.The catheter was replaced and resolved the issue.The procedure was completed without patient consequence.This event was originally considered non-reportable, however, bwi became aware of product was returned, clear sensor sleeve (pebax) is torn on the distal side of ring # 2 (cuts are next to the edge of ring) observed on january 14, 2015 and have reassessed the event as reportable.The bwi failure analysis lab received the device for evaluation.The returned device was visually inspected upon receipt and pebax was found torn on the distal side damaged that appears to be a cut on the distal side of ring # 2 allowing reddish brown material inside the area.Due to the pebax condtion, a scanning electron microscope (sem) was carried out and it was found that the damage presented evidence to be induced by a sharp object due to the pattern observed on the damaged area.Ring # 1 and dome were also analyzed and scratches were found.However, it remains unknown how the catheter pebax was damage.This type of peebax damage is further investigated under an internal corrective action.Per the event reported the catheter failed during the carto test error 3 was displayed.Further examination showed that the sensor was within specifications and pc board had a short circuit.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.Management is notified of failure analysis results using monthly complaint trend reporting.An internal corrective action was created to address a potential pcb issues/intermittency as well as to address the damaged pebax on smart touch.

• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4485038
• MDR Text Key: 5566965
• Report Number: 9673241-2015-00066
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2014

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: 12/31/2014
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 16041212M
• Other Device ID Number: (01)10846835009200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 02/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2014
• 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