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

Model Number D-1336-02-S

Device Problems Device Contamination with Chemical or Other Material (2944); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® uni-directional navigation catheter and a non-mdr reportable temperature issues occurred.Per the event description, there was no consequence to the patient and the procedure was completed using a similar like device.The bwi failure analysis lab received the complaint device for analysis.Analysis discovered reddish brown material inside the pebax area.The pebax area houses the spring of the catheter.Further examination revealed that the pebax is torn in two areas.This event is mdr reportable due to the hole found in the pebax area.The awareness date was updated for this complaint to (b)(6) 2015, the date said issue was discovered in the bwi lab.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).The product has been received by bwi, but the investigation is not yet completed.

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an atrial fibrillation procedure with a thermocool smarttouch uni-directional navigation catheter and a non-mdr reportable temperature issues occurred.The bwi failure analysis lab received the complaint device for analysis and discovered that the pebax, the area that houses the spring of the catheter, was torn in two areas and had reddish brown material inside of it.This event was mdr reportable due to the loss of integrity of the catheter at the pebax area.Upon receiving, the catheter was visually inspected and the clear sensor sleeve (pebax) was found torn in two places allowing reddish brown material similar to human blood inside.A scanning electron microscope (sem) testing was performed over the damaged area of catheter and results showed clear evidence of mechanical damage on the dome material.Moreover, the pebax material presented evidence of elongations and deformations caused by a peeling off condition; scratches marks were also found.Since that the damaged pebax section corresponds to the scratches found on the dome, it is very likely that the unknown object which caused mechanical damage to the dome, also caused damages to the pebax as well.Per the temperature issue reported by the customer, the returned device was then evaluated for electrical resistance, thermocouple test and generator.The catheter failed during the generator test, high temperature readings were observed.Further examination revealed that the thermocouple wires had an inadequate soldering.The customer complaint of temperature issues has been verified.Internal corrections were opened to investigate the issue of damaged pebax areas for the smart touch catheter families.The device history record was reviewed and no anomalies were found related to this complaint.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-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: jaime chavez ; 9098398483
• MDR Report Key: 4516688
• MDR Text Key: 5405050
• Report Number: 2029046-2015-00039
• 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: 01/07/2015

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: 09/30/2015
• Device Model Number: D-1336-02-S
• Device Catalogue Number: D133602
• Device Lot Number: 17096471M
• Other Device ID Number: (01)10846835009002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 02/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2014
• 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