MAUDE Adverse Event Report: COOK, INC. INTRODUCER - FLEXOR CHECK-FLO RAAB 8FR; INTRODUCER, CATHETER

Model Number G11637

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Intra-Abdominal Hemorrhage (4479)

Event Date 12/08/2021

Event Type  Death  

Event Description

Failure of sheath requiring cutdowns for vessel repair and foreign body removal.Intra-abdominal hemorrhage due to vessel injury at the aortic bifurcation.Fda safety report id# (b)(4).

• Brand Name: INTRODUCER - FLEXOR CHECK-FLO RAAB 8FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 13110996
• MDR Text Key: 282968238
• Report Number: MW5106314
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2022
• Device Model Number: G11637
• Device Lot Number: 9417934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White