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 Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2015

Event Type  malfunction  

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).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a smart touch bidirectional catheter and a deflection issue occurred.The smart touch catheter suddenly could not be deflected as intended during the manipulation of the handle.The catheter was removed from the patient body and was confirmed to be unable to be deflected as intended.The issue was resolved by changing the catheter to another one.The procedure was completed without patient consequence.This event was originally assessed as not reportable as the potential risk that it could cause or contribute to a serious injury or death is remote.Biosense webster received the device for evaluation and during visual inspection it was discovered that the peek housing was cracked 360 degrees around the entire circumference of the catheter.There were no internal parts exposed and the peek housing is secure to the tip lumen although the polyurethane on the external side is missing in some areas.In addition, reddish brown material was found inside the pebax.These findings have been assessed as reportable since it was noted that the peek housing was almost detaching, although it was still attached.The description indicates that integrity of this catheter may not have been maintained.In addition, a scanning electron microscope analysis was done to the pebax and discovered the pebax material presented evidence of scratch marks and separation which indicates the catheter integrity was not maintained.Upon request additional information was received on the event that these damages were not noticed prior to sending the catheter back for analysis.The awareness date for this record is august 12, 2015 because that is when the damage was discovered.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a smart touch bidirectional catheter and a deflection issue occurred.Upon receiving, the catheter was visually inspected and inside the clear sensor sleeve (pebax) a reddish brown material similar to human blood was found.A scanning electron microscope (sem) analysis was performed over the area of catheter and results showed clear evidence of mechanical damage on dome, electrode #2 and #3.Moreover, the pebax material presented evidence of scratches and separation.Considering that the pebax damaged section was found in the same line where the mechanical damage was located, it is very likely that the same object caused both damages.An internal corrective action was opened to continue investigating damaged pebax on smart touch catheter families.Continuing with the visual inspection, the peek housing was found cracked in the transition with tip section.During the analysis an x-ray of the catheter was taken and it was noticed that the cracks were caused by the migration of the t-bars which applied stress at the area while sliding down and finally getting caught at the tip section causing bumps.Peek housing dome and electrodes were still attached to the lumen by polyurethane and the catheter internal components.Further information received stated that physical damages found during the visual inspection on the catheter were not noticed prior to sending the catheter back.An internal corrective action was opened for the t-bar issue.An internal corrective action was opened for the peek housing issue.Due to the t-bars being out of place, the deflection test failed, concluding that the t-bar is the root cause of the deflection issue reported by the customer.The device history record (dhr) was reviewed and no anomalies were found.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has been verified.

• 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: shahe garabedian ; 9098397362
• MDR Report Key: 5069184
• MDR Text Key: 26986835
• Report Number: 9673241-2015-00626
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• 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-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17218049M
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2015
• 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