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

Model Number D134701

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).(b)(4).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30441448l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and developed st segment elevation required unspecified treatment in the intensive care unit (icu).During the procedure, about five hours since the ablation procedure had started, st segment elevation was noted.Reminder of the procedure was terminated.The patient was moved to the intensive care unit and received unspecified treatment.There¿s no report of prolonged hospitalization, it is unknown whether the patient was discharged from the hospital.It was reported there¿s no issue with the patient¿s current condition.Physician¿s causality opinion was not provided.No bwi product malfunctions were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

On 5/24/2021 an update was received stating that the patient had fully recovered.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 11839562
• MDR Text Key: 251125205
• Report Number: 2029046-2021-00775
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2021
• Device Model Number: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 30441448L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LASSO NAV 2515,12P SPLITHANDLE; PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO GE 8F CATHETER; LASSO NAV 2515,12P SPLITHANDLE; PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO GE 8F CATHETER
• Patient Outcome(s): Other