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

Catalog Number D134805

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2018

Event Type  malfunction  

Manufacturer Narrative

The investigational analysis has been completed.The catheter was visually inspected and reddish material was found inside the pebax with no damage observed.Irrigation testing was performed and it was found to be within specifications.The catheter was irrigating correctly.No irrigation issues were observed.Additionally, a scanning electron microscope (sem) testing was performed on the pebax and the results showed evidence of mechanical damage, stress marks, and a hole on the surface of the pebax.It is possible that the 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 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 was not confirmed.The root cause of the pebax damage cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

It was reported that a patient underwent an abalation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and during priming, an irrigation hole was clogged up.The catheter was replaced and the issue resolved.The procedure was completed without patient consequence.The potential it could cause or contribute to a serious injury or death is remote.Therefore, the issue has been assessed as not reportable.This event is being reported because the bwi failure analysis lab received the device on for evaluation and the 6/4/2018 fal findings from the scanning electron microscope (sem) showed evidence of mechanical damage, stress marks and a hole on the surface of the pebax.The finding of a hole in the pebax has been assessed as a reportable malfunction.The awareness date has been reset to june 6/4/2018.

• 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: 7653379
• MDR Text Key: 113016064
• Report Number: 2029046-2018-01743
• 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: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2018
• Device Catalogue Number: D134805
• Device Lot Number: 17740169L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1