MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134805

Device Problems Signal Artifact/Noise (1036); Material Frayed (1262); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Product investigation summary: the device was visually inspected and it was found in normal condition, then, during the second visual inspection, the electrode #2 was found damaged and lifted with white material observed inside.No damages were observed on the pebax area.Then, the electrical test was performed and the catheter failed, no electrical readings were observed on electrode # 2, this could be related to the damage observed.Then, the catheter outer diameter was measured and it was found within specifications.Additionally, per the damage observed a scanning electron microscope (sem) testing was performed and the results showed evidence of mechanical damage and stress marks on the surface of the ring; however, no sharp edges were found.There was foreign material embedded in the ring.It is possible that the damage was generated with an unknown object.No other anomalies were observed.Per the foreign material observed, a fourier transform infrared spectroscopy test (ftir) was performed and the results showed that the foreign material is presumably composed of polyethylene with barium sulfate, this composite material is widely used as redio pacifier along 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.During the manufacturing process, inspections and functional tests are in place to prevent this type of failure from leaving the facility.The customer complaint was confirmed.The root cause of the foreign material and the damage observed, could be related to the manipulation of the device during the procedure.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a signal loss was encountered.When the catheter was connected, the electrical potentials were not displayed.The issue was resolved by changing the catheter to another one.The procedure was completed without patient's consequence.The issue of "signal loss" is not a reportable issue.On 2/12/2018, the product was returned to biosense webster inc.(bwi) for evaluation.Initial visual analysis determined the catheter appeared in normal condition.On (b)(6) 2018, second visual analysis identified ring #2 was damaged/lifted and a white material was observed inside.The issue of damaged electrode rings is considered a reportable malfunction.Additionally, the issue of foreign material is also considered a reportable malfunction.As such, the awareness date of reportable malfunctions is (b)(6) 2018.On 3/21/2018, further evaluation of the catheter included scanning electron microscope (sem) testing.Sem results showed evidence of mechanical damage and stress marks on the surface of the ring; but no sharp edges were found.There was foreign material embedded in ring.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7439051
• MDR Text Key: 106417214
• Report Number: 2029046-2018-01425
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/19/2018

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: 05/31/2018
• Device Catalogue Number: D134805
• Device Lot Number: 17692203L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2017
• 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