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

Model Number A-FASE-DF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 10/31/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturing ref: 3005334138-2020-00585.One day post procedure, the patient had a stroke.The patient had an elective ventricular tachycardia (vt) ablation which went well.However, one day post procedure, the patient developed some non-fluency of speech and was reviewed by the stroke team.A head ct showed a subacute left lacunar infarct.The patient has peripheral vascular disease which was seen during the procedure and mild aortic stenosis which may have also contributed to this event.The patient¿s symptoms resolved, and the patient was discharged home.

Manufacturer Narrative

Additional information: b5, b7.Corrected information: d4.Corrected information: g1: additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided in g1.The correct mfr number is xxxxx.¿ (no year or sequential number).

Event Description

Additional information: the patient was anticoagulated 6 hours after sheath pull with a doac, to reduce groin complications.He was given rivaroxaban 20 mg.Transient symptoms (dysphasia) developed the next day and then resolved.There were no performance issues with any abbott devices.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported stroke remains unknown.

• Brand Name: FLEXABILITY ABLATION CATHETER-UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10864844
• MDR Text Key: 217088807
• Report Number: 3005334138-2020-00586
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A-FASE-DF
• Device Catalogue Number: A-FASE-DF
• Device Lot Number: 7628177
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 11/09/2020; 01/06/2021
• Supplement Dates FDA Received: 12/15/2020; 01/11/2021
• Patient Sequence Number: 1
• Treatment: ADVISOR¿ HD GRID CATHETER, SE
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 70