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

Model Number G47940

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/01/2019

Event Type  malfunction  

Event Description

While md was accessing right internal jugular (rij) with wire, wire was stuck near rij region.Md's involved in case aware.Wire was left in body.The device was not advanced into the lumen of the ij, as it should have been.Because of this, the device was stuck, and the md did not have the ability to safely remove it.

• Brand Name: MICROPUNCTURE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9347238
• MDR Text Key: 167156750
• Report Number: 9347238
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G47940
• Device Catalogue Number: MPIS-401-SST
• Device Lot Number: 9763188
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5110 DA