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

Catalog Number D134805

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a broken tip occurred.During the procedure, after 45 minutes, a current leakage error displayed on the carto 3 system and the system froze.The catheter was immediately checked, and damage was noted near the proximal electrodes, where the tip connects with the shaft.The damage resulted in exposed wires.However, there were no lifted or sharp rings.It was noted that there was no resistance or difficulty during insertion or removal of the smarttouch sf catheter.Smarttouch sf catheter was replaced, and the procedure was completed with no patient consequences.The current leakage error is not mdr reportable as patient safety is unaffected by this issue.However, the tip damage is mdr reportable.

Manufacturer Narrative

On 10/17/2018, the bwi failure analysis lab received the device for evaluation.Initial visual analysis identified, ¿a small bump where pick housing meets the shaft.¿ this finding was assessed as not mdr reportable since there is no exposure of internal components, or any evidence that the integrity of the catheter has been compromised, then the potential that it could cause or contribute to a death, serious injury, or other significant adverse event is remote.Product evaluation details: it was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a broken tip occurred.During the procedure, after 45 minutes, a current leakage error displayed on the carto 3 system and the system froze.The catheter was immediately checked, and damage was noted near the proximal electrodes, where the tip connects with the shaft.The damage resulted in exposed wires.The product evaluation has been completed.The device was visually inspected and a small bump was observed on the peek housing, no metal was exposed.Magnetic sensor functionality was tested on carto and the catheter was properly visualized; no errors were observed.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Per the damage observed, the deflection test was performed and the catheter failed.A failure analysis was performed and the catheter was dissected on the tip area, the t-bar was found slid down causing the improper deflection condition, also, residues of pu application was found at the t-bar anchored place which indicates a proper manufacturing assembly.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 was confirmed.The bump observed on the tip is related to the t-bar issue, since the t-bar had slid down causing stress on the area.The root cause of the t-bar slippage cannot be determined, however, an internal corrective action has been opened to investigate the issue of deflection issue and t-bar slippage.The root cause of the current leakage reported by the customer, cannot be determined since no malfunction was observed during the test that could cause the issue.Similar complaints are monitored monthly.Manufacturer¿s ref # (b)(4).

• 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: 7906454
• MDR Text Key: 121722243
• Report Number: 2029046-2018-02102
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30024813L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2018
• 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