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

Model Number 203CX

Device Problems Device Alarm System (1012); Deflation Problem (1149); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2020

Event Type  malfunction  

Event 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
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 9967294
• MDR Text Key: 187900659
• Report Number: 9967294
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 00643169950146
• UDI-Public: (01)00643169950146(17)210522(10)46005
• 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
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 203CX
• Device Lot Number: 46005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Weight: 94