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

Model Number D-1348-05-S

Device Problems Hole In Material (1293); Device Displays Incorrect Message (2591); Device Contamination with Chemical or Other Material (2944); Material Protrusion/Extrusion (2979)

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

Event Date 06/15/2017

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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch bidirectional sf catheter.Initially, it was reported that a 106 force sensor error displayed on the carto 3 system.The cable was replaced without resolution.The catheter was replaced and the issue resolved.The procedure was completed without patient consequence.This issue was assessed as not reportable as the warning functioned as intended.The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.The biosense webster failure analysis lab noted on the first visual inspection (b)(6) 2017 that the clear pebax sleeve had metal exposed at 7 and 9 mm from the distal end of the tip dome with reddish brown material inside it.At this time, it was assessed that the returned catheter condition was a reportable malfunction as the exposure of the metal represents a break of catheter integrity that poses patient risk.However, after further review under the microscope, metal was not found exposed.Reddish brown material was found under the pebax.Therefore, the catheter was then sent for scanning electron microscope (sem).The sem results showed evidence of two holes, scratches, stress marks and mechanical damage on the surface of the pebax.Since there were holes on the pebax that could cause the foreign material to travel into the blood circulation, the pebax damage condition remains a reportable malfunction.The awareness date was reset to (b)(4) 2017.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart touch bidirectional sf catheter.It was reported that a 106 force sensor error displayed on the carto 3 system.The cable was replaced without resolution.The catheter was replaced and the issue resolved.The procedure was completed without patient consequence.The returned device was visually inspected and it was found reddish brown material under the pebax with metal exposed.The catheter was evaluated for eeprom, and the functionality of the sensor catheter was tested on carto system.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was recognized by carto 3 system, however error 106 was displayed.The catheter was then dissected and it was determined that the root cause was an internal failure of the sensor.For the condition observed a scanning electron microscope (sem) testing was performed and the results showed evidence of two holes, scratches, stress marks and mechanical damage on the surface of the pebax.It is possible that damage was generated with an unknown object.No other anomalies were observed.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.During the manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint has been verified.The root cause of the loss of electrical continuity at the sensor could not be determined.The root cause of the damage remains unknown.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV 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: 6797328
• MDR Text Key: 83741487
• Report Number: 9673241-2017-00648
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: (01)10846835010183(11)170411(17)180331(10)17661103L
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• 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,Followup
• Report Date: 06/15/2017

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: 03/31/2018
• Device Model Number: D-1348-05-S
• Device Catalogue Number: D134805
• Device Lot Number: 17661103L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 08/16/2017
• Supplement Dates Manufacturer Received: 06/15/2017; 06/15/2017
• Supplement Dates FDA Received: 08/30/2017; 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• 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