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

Model Number D-1347-02-S

Device Problems Break (1069); Computer Software Problem (1112); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned device was visually inspected and it was found reddish material inside the pebax however, no visible damage was observed.The catheter was evaluated for carto 3 functionality and it was recognized by the system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was evaluated for screening test and catheter passed.The force feature was working properly.Finally, the force sensor values were found within specifications.For the condition observed, a scanning electron microscope (sem) testing was performed and the results showed results showed evidence of a hole and stress marks 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 manufacturing process, all 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 confirmed.The root cause of the damage on pebax cannot be determined since there is evidence that the catheter was manufactured in accordance with documented specification and procedures, it could be related to the handling of the product during the procedure, however, this cannot be conclusively determined.

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smarttouch® sf uni-directional nav catheter and a force issue occurred.There was incorrect force measurement during mapping and difficulty zeroing the catheter.The carto 3 system accepted zeroing after the third attempt.At the beginning of ablation, the force value increased immediately from 7 g to 120 g.This increase was reproducible three times.The catheter was changed and the issue resolved.The procedure was completed with no patient consequence.When the faulty catheter was removed, blood was seen inside of the catheter tip.These issues were originally assessed as not mdr reportable because the potential that it could cause or contribute to a death, serious injury, or other significant adverse event is low.The device was returned to the biosense webster failure analysis lab on (b)(6) 2017 and during visual inspection it was discovered that the clear pebax sleeve at the tip of the catheter had dark reddish-brown material inside the sleeve with no visible damage.This finding coincides with the reported event and remains not mdr reportable.If blood was found underneath the pebax, however there is no damage to the pebax integrity, then the potential that it could cause or contribute to a death, serious injury, or other significant adverse event is remote.During product analysis, on (b)(6) 2017, scanning electron microscope results showed evidence of a hole and stress marks on the surface of the pebax.It is possible that the damage was generated with an unknown object.This finding is mdr reportable because the exposure to internal parts poses a potential risk to the patient.The awareness date has been reset to (b)(6) 2017, the date of the reportable finding.

• Brand Name: THERMOCOOL® SMARTTOUCH® SF UNI-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: 6917399
• MDR Text Key: 90177291
• Report Number: 9673241-2017-00681
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 1084683500978
• UDI-Public: (01)1084683500978(11)161119(17)171031(10)17608094L
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• 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: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: D-1347-02-S
• Device Catalogue Number: D134702
• Device Lot Number: 17608094L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2016
• 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