MAUDE Adverse Event Report: MEDTRONIC FLEXCATH 15 FR SHEATH; CATHETER, STEERABLE

Device Problem Positioning Problem (3009)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 01/14/2019

Event Type  Death  

Event Description

Ath is not manufactured or imported by biosense webster, inc.Event description: it was reported that during an crye atrial fibrillation procedure, the patient was noted to have an "pericardia! effusion" on ice.The physician had attempted to "re-cross during a case" with a medtronic sheath and in that process the patient experienced low blood pressure values.Using ice, an effusion was noted in the left ventricle.A pericardiocentesis was performed with 700cc of blood/fluid withdrawn.At the time, the patient stabilized.After stabilizing the patient, the patient ended up with further bleeding and went to the operating room for surgery.Despite the surgery and fluid replacements, the patient ultimately expired.The only biosense webster, inc.Catheter in use (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: FLEXCATH 15 FR SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17537568
• MDR Text Key: 321041228
• Report Number: MW5144441
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1