MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1327-04-S

Device Problems Increase in Pressure (1491); Material Protrusion/Extrusion (2979); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a smart touch bidirectional catheter and a force issue occurred.The smart touch catheter was giving high force readings (20 grams) even when the catheter was not in contact with anything.The cable was replaced with no resolution.When the catheter was replaced, the issue resolved.There was no patient consequence.Additional information was received on the event.The catheter was not in close proximity to another catheter.The catheter was zeroed after the initial warm up phase.This event was originally assessed as not reportable, as the force issues potential risk to cause or contribute to a serious injury or death to the operator or patient is remote.When the catheter was returned to biosense webster for analysis, it was discovered that the clear sensor sleeve (pebax) has been torn open with a piece of pebax material sticking up in this area which allowed reddish brown material inside.Upon request, additional information was received on the returned catheter condition.There was no difficulty withdrawing the catheter through the sl2 8.5f sheath.The condition was not noticed prior to use, upon withdrawal or prior to sending the catheter back for analysis.The damage to the pebax is indicative of a reportable event.The awareness date for this record is (b)(6) 2015 because that is the day the damage was discovered.

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 a paroxysmal atrial fibrillation procedure with a smart touch bidirectional catheter and a force issue occurred.The returned device was visually inspected upon receipt and clear sensor sleeve (pebax) was torn open with piece of pebax material sticking up the area allowing reddish brown material inside, this finding is why this complaint was reported to the fda.A scanning electron microscope (sem) testing was performed over the damaged area of catheter and the results showed clear evidence of mechanical damage on the dome and ring #3 material.Moreover, the pebax material presented a pin hole and scratches.It is very likely that the unknown object which caused the mechanical damage caused the pebax damage material as well.This issue is further investigated under and internal corrective action.All the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.The catheter was evaluated for screening test and force calibration check and catheter passed both tests.The catheter was recognized by the carto 3 system, no error messages were displayed and the catheter was properly visualized.The force feature was working properly.Finally, the force sensor resistance values were found within specifications.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.

• Brand Name: THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4799831
• MDR Text Key: 21089948
• Report Number: 2029046-2015-00146
• 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: 04/17/2015

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: 08/31/2015
• Device Model Number: D-1327-04-S
• Device Catalogue Number: D132704
• Device Lot Number: 17096707M
• Other Device ID Number: (01)10846835009194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 05/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2014
• 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