MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH INTRODUCER; INTRODUCER, CATHETER

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Retroperitoneal Hemorrhage (4483); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2023

Event Type  Injury  

Event Description

Following an atrial fibrillation cryo ablation procedure, a retroperitoneal bleed was discovered.Blood and plasma were administered and a right chest tube was placed to stabilize the patient.The patient had blood pressure issues following the procedure before they crashed.The retroperitoneal bleed was confirmed by echocardiogram and computed tomography.Blood and fresh frozen plasma were administered, as well as placing a right chest tube and the patient was reported to be in stable condition.The physician believes the injury was related to vascular access at the beginning of the procedure.

Manufacturer Narrative

Upon review of the file it was determined this is a duplicate event.The details of the investigation will be submitted via that mdr-2023-43592-01.

Event Description

Upon review of the file it was determined this is a duplicate event.The details of the investigation will be submitted via that mdr-2023-43592-01.

• Brand Name: FAST-CATH INTRODUCER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17788204
• MDR Text Key: 323918540
• Report Number: 3005334138-2023-00431
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1