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

Catalog Number D133602

Device Problems Entrapment of Device (1212); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 10/18/2018

Event Type  Injury  

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.The device history record (dhr) for the lot number 30032751m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(4).Manufacturer's reference # (b)(4).

Event Description

It was reported that an (b)(6) male patient underwent a left sided ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter in which the deflection of the catheter was stuck and a medical device entrapment occurred requiring surgical intervention.During the procedure, the catheter deflection stopped working.The catheter got stuck in a fully deflected position at the height of the femoral artery.The physician tried to remove the catheter from the patient¿s body to check the tip and deflection; however, it was not possible.He tried to remove it taking a long time, but the catheter seemed to be tangled with the introducer.The catheter was cut, and a wire was introduced trying to put the catheter straight, but it did not work.The patient was transferred to the operating room (or) to have an open-heart surgery that was required to extract the catheter.The patient was reported to be in stable condition after surgery.Extended hospitalization was required for recovery purposes.Patient¿s outcome is fully recovered with no residual effects.Physician¿s opinion regarding the cause of the adverse event is that it was related to a biosense webster, inc.-product malfunction.Relevant test/lab data reflected that the inr was 1.32.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.The issues of the catheter curve stuck in deflected position with full tension on curved tip and the medical device entrapment have been assessed as reportable issues.

Manufacturer Narrative

Originally the lot number reported was 30032751m.However, the biosense webster inc.Product analysis lab received the device for evaluation on november 26, 2018 and the lot number was 17742744m.Clarification was requested and a response was received on december 13, 2018 confirming that the correct lot number was 17742744m.The catheter was returned in the condition reported as it was stated,"the physician tried to remove the catheter taking a long time, but the catheter seemed to be tangled with the introducer.The catheter was cut." the biosense webster inc.Product analysis lab described the returned product condition as the distal tip appears to be cut.Populated lot,.Device available for evaluation?.Is device returned to manufacturer? and date device returned to manufacturer.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.The device history record, manufactured date and expiration date have been provided on december 20, 2018.Therefore, fields expiration date, manufactured date and unique identifier( udi) have been populated.The device history record (dhr) for the lot number 17742744m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

Investigation summary: it was reported that an 80-year-old male patient underwent a left sided ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter in which the deflection of the catheter was stuck, and a medical device entrapment occurred requiring surgical intervention.During the procedure, the catheter deflection stopped working.The catheter got stuck in a fully deflected position at the height of the femoral artery.The physician tried to remove the catheter from the patient¿s body to check the tip and deflection; however, it was not possible.He tried to remove it taking a long time, but the catheter seemed to be tangled with the introducer.The catheter was cut, and a wire was introduced trying to put the catheter straight, but it did not work.The patient was transferred to the operating room (or) to have an open-heart surgery that was required to extract the catheter.The patient was reported to be in stable condition after surgery.Extended hospitalization was required for recovery purposes.Patient¿s outcome is fully recovered with no residual effects.The device was inspected, and the distal tip was found cut.The tip was not returned as per the reported event it was stated that during the procedure, the tip was cut.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.There are several tests on line to test the device including deflection test, we have evidence that the device was manufactured in accordance with documented specification and procedures.In addition, the handle was inspected under the x ray and the puller wire was found within manufacture specifications.For the catheter condition, the failure analysis was unable to be performed; however, we have evidence that the device was manufactured in accordance with documented specification and procedures.The complaint was confirmed due to the information received from the customer; however, this issue cannot be related to the manufacturing of the catheter.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade, and no excessive force to advance or withdraw the catheter when resistance is encountered during the manipulation of the catheter through the sheath.Manufacturer's reference#: (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: 8076830
• MDR Text Key: 127340751
• Report Number: 2029046-2018-02266
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2018
• Device Catalogue Number: D133602
• Device Lot Number: 17742744M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 11/26/2018; 01/16/2019
• Supplement Dates FDA Received: 12/26/2018; 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 75