MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133602

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

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.We are working on the manufacture record evaluation (mre), once we get more information it will be submitted in the supplemental.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient, underwent an ablation procedure for ventricular tachycardia (vt) with a thermocool® smart touch¿ electrophysiology catheter, and a device entrapment issue occurred.During the procedure, after inserting the ablation catheter in the left ventricle, and obtaining the activation map of the target area, the ablation catheter was "pushed" from the left ventricle in the ascending aorta.Reinsertion of the catheter was attempted, but the left ventricle was blocked due to a loop that resulted in the distortion of the catheter.The catheter bent under the curve and it was folded in two.The physician attempted to retract the catheter to the descending aorta, but it could not be retracted to the femoral area, nor advanced in the ventricle.The catheterization department representative was called to retract the catheter from the patient body.After several attempts the catheter was retrieved.To straighten the catheter curvature, a support catheter was used.The procedure was delayed 1.5 hrs.The physician observed that the catheter was stiff and hard.There was no patient consequence.Product stored as per labeled conditions.The patient was under local anesthesia, during the procedure for 4 hours.The patient did not have a high risk health status.In the physician¿s opinion the event did not contribute to a serious injury.No extended hospitalization was required.The damage did not result in wires being exposed or sharp rings.The bend in the catheter was close to the tip curve.The catheter was not pre-shaped.A sheath was not used for catheter insertion.It was very difficult to remove the catheter from the patient.The catheter was removed by doctors from the catheterization department.They retracted the catheter to the iliac artery, blocked the catheter tip in an iliac branch, and straightened the catheter curve.No adverse patient consequences were reported.The observed device entrapment issue has been assessed as not mdr reportable.

Manufacturer Narrative

It was reported that a patient, underwent an ablation procedure for ventricular tachycardia (vt) with a thermocool® smart touch¿ electrophysiology catheter, and a device entrapment issue occurred.Biosense webster inc.(bwi) product analysis lab received the device for evaluation.Upon initial inspection, the device was found in good normal condition.The investigational analysis completed 3/11/2020.The device was visually inspected and it was found in good conditions.The catheter was deflecting correctly and no stiffness was felt.In addition, the catheter outer diameter was found within specifications.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was not confirmed.The root cause of the reported experience by the customer could be related to the procedure, however, this cannot be conclusively determined.Manufacture reference no:(b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9564985
• MDR Text Key: 199533756
• Report Number: 2029046-2020-00033
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

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: 06/03/2020
• Device Model Number: D133602
• Device Catalogue Number: D133602
• Device Lot Number: 30232460M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM