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

Catalog Number D134804

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the device was inspected and the pebax was found cut on one side.Then, the catheter outer diameter was measured, and it was found within specification.Additionally, a scanning electron microscope (sem) testing was performed on the damage area and the results showed evidence of mechanical damage and a hole on the surface of pebax.It is possible that the damage was generated with an unknown object.No other anomalies were observed.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure.(b)(4).

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) with a thermocool® smart touch® sf bi-directional navigation catheter and it was reported that there was a cut on the pebax.Initially it was reported that when the procedure was finished and the thermocool® smart touch® sf bi-directional navigation catheter was pulled out of the patient¿s body, the tip of the thermocool® smart touch® sf bi-directional navigation catheter got stuck outside of the sheath.The physician was able to successfully remove the catheter after 5 attempts.The procedure was completed successfully.There was no patient consequence.Additional information was received on the event on (b)(6) 2019.There was resistance during the removal of the catheter.It was stated that there maybe damage in the area of the contact force sensor / spring; however, it was hard to judge just using visual inspection.There was no damage resulting in wires and or braid being exposed.Unable to see any damage to the rings.There was no partial or total detachment.The issue occurred with the tip dome, contact force sensor and spring.A mobicath larg was used in the procedure.The issue of medical device entrapment ¿ no excessive manipulation required was assessed as not reportable.If the device was able to be removed without surgical intervention, this is not reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation on april 4, 2019 and it was reported that there was a cut one side of the pebax.Therefore, on (b)(6) 2019 a scanning electron microscope (sem) analysis was performed and showed evidence of mechanical damage and a hole on the surface of pebax.The pebax integrity issue was assessed as a reportable issue.The awareness date for this issue is (b)(6) 2019.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8577636
• MDR Text Key: 145791156
• Report Number: 2029046-2019-03060
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2019

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: 11/26/2019
• Device Catalogue Number: D134804
• Device Lot Number: 30149260L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1