MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number AFAPRO28

Device Problem Gas/Air Leak (2946)

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

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, air was injected into the syringe by aspiration through the sheath.The balloon catheter was replaced.The case was completed with cryo.

Manufacturer Narrative

Correction: b5 product event summary: the balloon catheter afapro28 with lot number 56876 was returned and analyzed.Visual inspection showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was not used.The catheter passed the performance test and electrical integrity as per specification.Dissection and pressure testing did not show any leaks or traces of liquid or blood inside the catheter.In conclusion, the reported air ingress has not been confirmed through testing.The balloon catheter passed the returned product inspection as per specification.If information is provided in the future, a supplemental report will be issued.

Event Description

No patient complications have been reported as a result of this event.

• Brand Name: ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 9634592
• MDR Text Key: 195260422
• Report Number: 3002648230-2020-00052
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• PMA/PMN Number: P100010/S015
• 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: 02/27/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2021
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 56876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4FC12 SHEATH