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

Model Number D-1336-02-S

Device Problems Break (1069); Device Displays Incorrect Message (2591); Material Integrity Problem (2978)

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

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the returned device was visually inspected upon receipt and reddish material and a cut were found at the pebax area.Per this condition a scanning electron microscope (sem) testing was performed over the damaged area of catheter and it was found that the pebax external surface presented evidence of scratches and a pin hole induced by an unknown object.The catheter was evaluated for screening test and force calibration check and catheter passed both tests.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.The force feature was working properly.The force sensor 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.

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a thermocool smarttouch uni-directional navigation catheter and a force issue occurred.During the mapping phase, the force reading of the smarttouch catheter was giving an error of two catheters being too close to each other, although at that time the lasso catheter was placed in the opposite side of the vein from the ablation catheter; one was at left side of left atrium and the other was at right side of left atrium.The contact force showed a grey value.The catheter was changed and the procedure was completed with no patient consequence.This event was originally assessed as not mdr reportable because the risk to the patient is low.The device was returned to biosense webster failure analysis lab for evaluation on january 8, 2016 and it was discovered that there was reddish brown material under the pebax in addition to a cut on the pebax.Upon request additional information was received on the returned catheter condition.After the force issue, the physician then pulled out the catheter and it was noticed that there was red patches near the tip of catheter.The catheter was then replaced with another smarttouch catheter and procedure continued.There was no difficulty in removing the catheter through the 8.5f sl0 sheath by st jude medical.The returned catheter condition was not noticed prior to use, however the "red patches" were noticed upon withdrawal and prior to sending the catheter back for analysis.This event was then reassessed as mdr reportable because the cut to the pebax caused a break in catheter integrity and poses a potential risk to the patient.The awareness date for this record is january 8, 2016 because that is when the damage was discovered.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-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: joaquin kurz ; 9497893837
• MDR Report Key: 5392253
• MDR Text Key: 37726611
• Report Number: 9673241-2016-00046
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Type of Report: Initial
• Report Date: 11/13/2015

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: 06/30/2016
• Device Model Number: D-1336-02-S
• Device Catalogue Number: D133602
• Device Lot Number: 17272086M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2015
• 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