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

Catalog Number D133604IL

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2019

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.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.A manufacturing record evaluation was performed for the finished device 30110969m number, and no non-conformances was found during the review.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter wherein the deflection mechanism became stuck in a deflected position.During the radiofrequency catheter ablation procedure there was an abnormal deflection and the thermocool® smart touch¿ electrophysiology catheter could not be straightened.The curve of the catheter was stuck in a full deflected position and they were unable to move the knob/piston up or down.There was no difficulty removing the thermocool® smart touch¿ electrophysiology catheter from the patient¿s body.There was no patient consequence.This event has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

On 3/1/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis identified the catheter was returned without a shaft.The finding itself is not reportable, however, the complaint remains reportable for the reported deflection stuck issue.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.Correction: h6 method code of 3331 (analysis of production records) was inadvertently omitted from the initial 3500a.It has now been added.Manufacturer's ref.(b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter wherein the deflection mechanism became stuck in a deflected position and could not be straightened.The curve of the catheter was stuck in a full deflected position and they were unable to move the knob/piston up or down.There was no difficulty removing the thermocool® smart touch¿ electrophysiology catheter from the patient¿s body.There was no patient consequence.Device evaluation details: the device evaluation has been completed.The device was inspected and found the shaft was not returned.Due to the catheter condition, the product analysis was unable to be performed.The customer provided two pictures in which the tip was observed bent, however, the deflection mechanism was unable to be investigated since the catheter was returned incomplete.A manufacturing record evaluation was performed and no non-conformances related to the reported complaint were identified.The customer complaint cannot be confirmed since the device was not returned complete.Due to the picture provided, the tip was bent, this bent cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.The issue could be related to the handling of the device during the procedure, however, this cannot be conclusively determined and there is not enough information to confirm the complaint.Manufacturer¿s ref # (b)(4).

• 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
• MDR Report Key: 8352418
• MDR Text Key: 139168508
• Report Number: 2029046-2019-02702
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2019

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: 09/18/2019
• Device Catalogue Number: D133604IL
• Device Lot Number: 30110969M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 03/01/2019; 04/08/2019
• Supplement Dates FDA Received: 03/07/2019; 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1