MAUDE Adverse Event Report: BARD ACCESS SYSTEM, INC. RADSTIC RADIOLOGY MICRO INTRODUCER KIT PEEL-APART SHEATH INTRODUCER 6.0FR; INTRODUCER, CATHETER

Catalog Number 0669050

Device Problems Break (1069); Entrapment of Device (1212); Retraction Problem (1536); Difficult to Advance (2920)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/21/2020

Event Type  Injury  

Event Description

Using the radstic radiology microintroducer via containing guide wire 0.46 mm x 70 mm.The left basilic vein was accessed using as guidance.Guide wire inserted, met resistance & during removal of guide wire had uncoiling of wire and breakage into two (2) pieces.End of wire lodged into the patient's arm.Radiologist removed the remaining piece of guide wire using fluoroscopy.

• Brand Name: RADSTIC RADIOLOGY MICRO INTRODUCER KIT PEEL-APART SHEATH INTRODUCER 6.0FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEM, INC. ; 605 n. 5600 west; salt lake city UT 84116
• MDR Report Key: 10454185
• MDR Text Key: 204616808
• Report Number: MW5096285
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 0669050
• Device Lot Number: REDY0622
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention