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 Bent (1059); Peeled/Delaminated (1454); Device Displays Incorrect Message (2591)

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

Event Date 07/06/2016

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.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smarttouch® bi-directional navigation catheter and a force sensor error displayed on the carto 3 system.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 remote.On august 24, 2016 the device was returned to the biosense webster failure analysis lab which discovered the proximal side of ring #3 had the peek housing bent leaving the ring rough and the polyurethane (pu) margin peeling on the proximal side.This finding has been assessed as mdr reportable because if the electrodes of catheter are dented, squashed, lifted or the pu border is damaged, then there is potential harm to the patient.The awareness date has been reset to the date the mdr reportable lab finding was discovered, august 24, 2016.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an ablation procedure with a thermocool® smarttouch® bi-directional navigation catheter and a force sensor error displayed on the carto 3 system.The returned device was visually inspected upon receipt and it was found that there was a rough margin and polyurethane (pu) peeling at the ring#3 caused by a bend at the peek housing area.This finding was assessed as mdr reportable.Further information was requested regarding the condition of the catheter, however at this moment it has not been available for bwi.A scanning electron microscope (sem) test was performed there was no evidence of mechanical damage that could be contributed to the bent condition.During manufacturing 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 the functionality of the sensors on carto system.The catheter was recognized by carto 3 system, however error 106 was displayed.The catheter was then dissected and it was found that there was a loss of electrical continuity on the force sensor.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 regarding a force sensor error has been verified however the root cause could not be determined.The root cause of the bend noticed at the catheter does not appear to be manufacturing related.

• 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5952739
• MDR Text Key: 55170809
• Report Number: 9673241-2016-00598
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(11)160521(17)170730(10)17435464M
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2017
• Device Model Number: D-1327-05-S
• Device Catalogue Number: D132705
• Device Lot Number: 17435464M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1