MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Model Number D-1336-05IL-S

Device Problems Break (1069); Crack (1135); Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)

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

Event Date 07/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned device was visually inspected and ring #2 was damaged with white foreign material underneath and the pebax was found damage with reddish material inside.The returned device was then evaluated for electrical resistance and current leakage and it failed on electrode #2.Further investigation revealed that the damage on the ring was causing the improper electrical condition.Per the condition observed, the catheter outer diameter was measured and it was found within specifications.Per the condition observed a scanning electron microscope (sem) testing was performed and the results showed evidence of a crack (hole) in the pebax/ring transition with mechanical damage and scratches on the surface of pebax and ring.It is possible that damage was generated with an unknown object.No other anomalies were observed.Per material observed a fourier transform infrared spectroscopy (ft-ir) was performed and the results showed that the material found was identified to be primary composed of polyethylene and barium sulfate, a plastic composite widely used on medical device industries.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 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.Based on available analysis finding results, the damage on the ring and pebax does not appear to be caused by any internal bwi processes since the device was manufactured in accordance with documented specification and procedures, it could be related to the manipulation of the catheter within the sheath, however this cannot be conclusively determined.

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smarttouch® uni-directional navigation catheter and the catheter had noise/interference.The catheter was changed and the issue resolved.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 the biosense webster failure analysis lab and on (b)(6) 2017, it was discovered that ring #2 was damaged.White foreign material was observed underneath ring #2.Reddish material was observed inside the pebax.In addition, on (b)(6) 2017, a scanning electron microscope analysis was performed and results showed evidence of a crack in the pebax ring transition with mechanical damage and scratches on the surface of pebax and ring.The electrode damage with foreign material and the damage to the pebax findings have been assessed as mdr reportable due to the potential for patient risk.The awareness date has been reset to (b)(6) 2017, the date the first reportable finding was discovered.

• Brand Name: THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 6979446
• MDR Text Key: 91220080
• Report Number: 9673241-2017-00691
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: D-1336-05IL-S
• Device Catalogue Number: D133605IL
• Device Lot Number: 17635844M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• 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