MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ 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 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

The device was visually inspected and blood was found inside the pebax with no visible damage.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor feature was tested and it was working properly, the force values were observed within specifications.In addition, a scanning electron microscope (sem) testing was performed on the damage area 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.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 confirmed.The root cause of the damage on pebax 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 ablation procedure for atrial fibrillation (afib) with a thermocool® smart touch¿ bi-directional navigation catheter, and blood was found in the pebax.During the procedure there was an issue with the contact force.No error messages displayed.Data did not appear to match the force, and the catheter was unable to zero.The cable was replaced and the issue resolved without patient consequence.This event was originally assessed as not mdr reportable because the potential it could cause or contribute to a serious injury or death is remote.The device was returned for analysis and on 4/30/2018 the failure analysis lab (fal) found blood in the pebax with no visual damage and no damage to the pebax integrity.The potential it could cause or contribute to a serious injury or death is remote.Therefore, the observed noise has been assessed as not reportable.This event is being reported because the on (b)(6) 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.Therefore, a hole in the pebax has been assessed a reportable issue.

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 7657134
• MDR Text Key: 113286015
• Report Number: 2029046-2018-01755
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 17759052L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1