MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

The device was visually inspected and white foreign material was found stuck on the tip, then, during the second visual inspection no foreign material was observed, this could be related to the decontamination process.Then, deflection test was performed, and the catheter failed.A failure analysis was performed, and the catheter was observed under the x ray machine and the t bar was found slid down causing the improper deflection condition.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 failure from leaving the facility.The customer complaint was confirmed.The root cause of the t bar slippage cannot be determined.An internal correction action has been open to investigation the issue of t bar slippage.The root cause of the foreign material cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.Similar complaints are monitored monthly.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter and a deflection issue occurred.It was reported that during the operation, the catheter could not deflect.The second catheter was used to complete the operation.No patient consequences were reported.The reported deflection issue itself is not reportable since the potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.On 9/17/2018, the bwi failure analysis lab received the device for evaluation and initial visual analysis identified, a white foreign material stuck at the tip of the catheter above ring #1 at approx 0.4 cm from distal tip.However, no other visual damages.The issue of foreign material observed on the usable length of the catheter has been reviewed and assessed as an mdr reportable malfunction.As such, the awareness date of the reportable malfunction is 9/17/2018.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 7961975
• MDR Text Key: 125605720
• Report Number: 2029046-2018-02155
• Device Sequence Number: 1
• Product Code: LPB
• 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: 09/17/2018

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: 02/18/2019
• Device Catalogue Number: D133604IL
• Device Lot Number: 30017176M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1