MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	A-FASE-FJ
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results will be provided in a subsequent submission. .
Event or Problem Description
At the beginning of an atrial fibrillation procedure, the non-abbott introducer was inadvertently inserted into the artery instead of the vein.The ablation catheter was inserted through the introducer but when the introducer location was discovered, the ablation catheter was attempted to be removed.The introducer had became folded and difficulty was noted removing the catheter.When the catheter was removed, the distal portion of the device detached into the sheath.The detached portion of the catheter and the introducer were successfully removed.The devices were replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The device was returned due to a detached distal tip and withdrawal difficulty.Two images were submitted to product performance engineering.One image appears to show the distal tip of the catheter detached inside the sheath.The other image appears to show the catheter with the distal tip detached without the sheath.Upon visual inspection the distal tip of the ablation catheter was detached from the catheter shaft.Due to the condition of the returned device, insertion/withdrawal testing was not possible.The catheter was returned with the 8f sheath.According to the ifu, "an 8.5 f minimum introducer sheath may be used to aid in insertion." the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the detached distal tip remains unknown.The cause of the withdrawal difficulty is due to device insertion into the incorrect anatomical location and the use of an incorrect sheath size.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8529550
• Report Number: 3008452825-2019-00183
• Device Sequence Number: 13928103
• Product Code: OAD
• UDI-Device Identifier: 05415067020086
• UDI-Public: 05415067020086
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2019

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 Expiration Date: 10/31/2021
• Device Model Number: A-FASE-FJ
• Device Lot Number: 6756525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 07/08/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 04/25/2019; 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1