MAUDE Adverse Event Report: COOK MEDICAL 4 FR MICROPUNCTURE ACCESS KIT; MICROPUNCTURE SHEATH

Catalog Number G48003

Device Problems Entrapment of Device (1212); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2021

Event Type  Injury  

Event Description

A 4 fr micropuncture (mp) needle was introduced into left internal jugular vein (lij) under us guidance, exchanging it over a glide wire to a 4 fr mp sheath.After making a small incision on the anterior aspect of the left-sided chest wall using a scapel blade, the dual lumen cuffed dialysis catheter measuring 23cm was advanced through a tunnel under the skin, to exit the venotomy site.Upon attempted removal of the micropuncture sheath over the guidewire, the distal part of the micropuncture fractured to stay within the vascular lumen over the guidewire, with the inability to retrieve it with the help of forcep/hemostat.A fluoroscopic image could not localize the presence of the fractured portion of the micropuncture sheath.Patient sent to ct for further imaging.Transferred to miami valley hospital for vascular surgery consult.Patient underwent an emergent left neck exploration for retained foreign body.Sheath was retrieved at the subclavian/lj junction.

• Brand Name: 4 FR MICROPUNCTURE ACCESS KIT
• Type of Device: MICROPUNCTURE SHEATH
• Manufacturer (Section D): COOK MEDICAL ; po box 4195
• MDR Report Key: 11703147
• MDR Text Key: 246766715
• Report Number: 11703147
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: G48003
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2021
• Distributor Facility Aware Date: 03/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 84