MAUDE Adverse Event Report: COOK INCORPORATED MICROPUNCTURE INTRODUCER SET; COOK MEDICAL INTRODUCER, CATHETER

Model Number G43869

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/19/2021

Event Type  Injury  

Event Description

While performing a tunneled hemodialysis catheter insertion, the hub of a micropuncture broke off and the catheter became a foreign object in the pt's right internal jugular vein.The catheter was retrieved via the right femoral vein with the aid of a snare and removed.Entire piece successfully removed.Assessment - non oliguric aki on ckd versus ckd progression, likely progressing to esrd-htn uncontrolled.

• Brand Name: MICROPUNCTURE INTRODUCER SET
• Type of Device: COOK MEDICAL INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; bloomington IN
• MDR Report Key: 12682382
• MDR Text Key: 278421913
• Report Number: MW5104896
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G43869
• Device Catalogue Number: MPIS-501-U-SST
• Device Lot Number: 14207074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 70