MAUDE Adverse Event Report: MEDTRONIC, INC. COAXIAL UMBILICAL ROHS; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	203CX
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Incident description: during cryo balloon ablation, a pop sound was heard when inflated balloon came on frezz (sp?).Deflated, removed balloon from the patient.Opened new balloon attached to umbilical cable.The same thing happened, with same error code: 50030, it said "try changing umbilical cable." when we did this, no problem.We continued with the procedure.The patient was stable when they left the procedure room.The procedure was completed with the following findings: findings: normal sinus rhythm at baseline with normal ah, hv, qrs and qt intervals with post ablation testing revealing absence of dual av node physiology.Successful pulmonary vein isolation using a cryo cath balloon of all 4 pulmonary veins for paroxysmal atrial fibrillation.Successful right atrial flutter ablation at the cavotricuspid isthmus with creation of bidirectional block.

• Brand Name: COAXIAL UMBILICAL ROHS
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 9967294
• Report Number: 9967294
• Device Sequence Number: 19792238
• Product Code: LPB
• UDI-Device Identifier: 00643169950146
• UDI-Public: (01)00643169950146(17)210522(10)46005
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/14/2020
• Report Date (Section F): 04/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 203CX
• Device Lot Number: 46005
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 94
• Date Report Sent to FDA: 04/14/2020