MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL SMARTTOUCH BI-DIRECTIONAL ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133601

Device Problem Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2021

Event Type  malfunction  

Event Description

After the ablation catheter was placed into the patient, an error connecting with the ablation system occurred.The catheter was removed and replaced w/o incident or harm to the patient.The catheter has been sent back to the vendor.

Event Description

After the ablation catheter was placed into the patient, an error connecting with the ablation system occurred.The catheter was removed and replaced w/o incident or harm to the patient.The catheter has been sent back to the vendor.

• Brand Name: THERMOCOOL SMARTTOUCH BI-DIRECTIONAL ABLATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 5110 commerce rd; baldwin park CA 91706
• MDR Report Key: 12834941
• MDR Text Key: 280944318
• Report Number: 12834941
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D133601
• Device Catalogue Number: D133601
• Device Lot Number: 30625539L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1