MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. REFLEXION¿ SPIRAL BI-DIRECTIONAL VARIABLE RADIUS CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D402893

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

Patient Problems Stroke/CVA (1770); Tissue Damage (2104)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

An event of a cva and vascular complications was reported.The results of the investigation are inconclusive since the device was not returned for analysis. additionally, a review of the device history record was not possible as a lot number was not provided. based on the information received, the cause of the reported cva and vascular complications is unknown.

Event Description

Related manufacturing ref: 2182269-2019-00189, 3005334138-2019-00595, 9680001-2019-00135.Following a persistent atrial fibrillation procedure, the patient experienced a thrombotic cerebrovascular accident (cva) and vasculature complications in his leg.Ice was performed before any invasive maneuvers and no thrombus was noted.The act was within the therapeutic range throughout the procedure and was reversed with protamine for sheath removal.Treatment was needed for the cva and vascular damage.The current patient status is unavailable.There were no performance issues with any abbott device.

• Brand Name: REFLEXION¿ SPIRAL BI-DIRECTIONAL VARIABLE RADIUS CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9267861
• MDR Text Key: 164660216
• Report Number: 2182269-2019-00190
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2019

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: D402893
• Device Catalogue Number: D402893
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AGILIS¿ NXT STEERABLE INTRODUCER; FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER; TACTICATH¿ CONTACT FORCE CATHETER
• Patient Outcome(s): Required Intervention