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

Model Number G47940

Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/01/2019

Event Type  malfunction  

Event Description

While doctor was accessing rij with wire, wire was stuck near right internal jugular.Physicians involved in case aware.Wire was left in body.While getting access to the right ij the fellow believed they were in the vein as they had good blood return and were using us.They advanced a micro puncture wire and met resistance.Upon trying to remove the wire it is believed the needle sheared the end of the wire and a portion less than 1cm was retained in the body.

• Brand Name: MICROPUNCTURE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9853277
• MDR Text Key: 184078967
• Report Number: 9853277
• 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: 02/12/2020

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: No Information
• 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: 02/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6570 DA