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 Hole In Material (1293); Material Integrity Problem (2978)

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

Event Date 12/08/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch bidirectional catheter and a force issue occurred.The contact force value of the smart touch catheter was displayed as spi mark and ¿na¿ during the ablation.The cable was changed but the issue continued.The issue was resolved by changing the catheter to another one.The procedure was completed without patient consequence.The event was originally assessed as not reportable because this is highly detectable and posed very low risk to the patient.This event is being reported because the bwi failure analysis lab received the device for evaluation on january 11, 2015 and found the clear sensor sleeve (pebax) had a small hole.This finding is reportable due to the loss of integrity of the device.This event was originally considered non-reportable; however, bwi became aware of the returned product condition on january 11, 2015 and have reassessed the event as reportable.

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).

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch bidirectional catheter and a force issue occurred.The returned device was visually inspected upon receipt and liquid was found inside the pebax.The initial inspection indicates that there was a small hole with very light blue material in that area and a scratch near ring #1, however during a detailed second inspection no hole or light blue material was observed.The scratch found near electrode #1 did not damage the integrity of the pebax material; it appears that this damage was caused by an external tool.This type of failures is further investigated under an internal corrective action.Ring #2 was slightly lifted allowing the liquid to get inside to the pebax area.No further information could be obtained whether this condition was noticed by the customer.Due to the ring damage, the catheter outer diameters were measured and it was found within specifications.Catheter was then introduced into an ifu recommended preface sheath and no friction or resistance was observed.The catheter was tested for biosensor and carto functionality.The catheter failed both.Biosensor readings were found lower than specifications and during the carto test error 105 was displayed.According to the biosensor results and the sensor readings, the improper condition was attributed to a potential pc board failure.An internal corrective action has been opened to address this pc board issue.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 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4479156
• MDR Text Key: 5322021
• Report Number: 9673241-2015-00061
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2014

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: 06/30/2015
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17054057M
• Other Device ID Number: (01)10846835009200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 02/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2014
• 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