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

Catalog Number D134805

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

Bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer¿s ref # (b)(4).

Event Description

It was reported a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and deflection issue occurred.It was reported that the steering mechanism (plunger) on this catheter was broken and the catheter was not able to deflect.The catheter was replaced, and the case resumed.There was no patient consequence.The deflection issue is not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On 11/26/2018, the biosense webster inc.Failure analysis lab (fal) received the complaint device for evaluation.During initial visual analysis, foreign material was found on the distal tip of the catheter.This issue has been assessed as mdr reportable.This event was originally considered nonreportable, however, bwi became aware of a reportable malfunction on (b)(6) 2018 and have reassessed the event as reportable.

Manufacturer Narrative

On (b)(6)2018, the device history record (dhr) for the lot number 30088162l was reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref # (b)(4).

Manufacturer Narrative

It was reported a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and deflection issue occurred.The deflection issue is not mdr reportable.On (b)(6)2018, the biosense webster inc.Failure analysis lab (fal) received the complaint device for evaluation.During initial visual analysis, foreign material was found on the distal tip of the catheter.This issue has been assessed as mdr reportable.Device evaluation details: the device evaluation has been completed.The device was visually inspected and foreign material was observed on the tip.A deflection test was performed and it was found within specifications, the catheter was deflecting correctly.Then, an electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.The catheter was connected to the cool flow pump and the catheter was found occluded, this is related to the foreign material on the tip.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that foreign material was primarily composed of a biological-based material, presumably human tissue.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 cannot be confirmed.The root cause of the foreign material observed on the tip could be related to the procedure, since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the procedure, however, this cannot be conclusively determined.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
• MDR Report Key: 8154731
• MDR Text Key: 130061780
• Report Number: 2029046-2018-02439
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2018

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: 08/01/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30088162L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 12/20/2018; 01/21/2019
• Supplement Dates FDA Received: 12/26/2018; 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1