MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC STIFFEN MICRO-INTRODUCER KIT 4F; INTRODUCER, CATHETER

Model Number 7266V

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/12/2019

Event Type  Injury  

Event Description

During a left heart catherization with coronary angiogram and right heart catherization when the cardiologist was getting venous access with micro puncture kit.A 4fr sheath broke off in patient under the skin at hub of sheath.Surgeon had to be called to remove device.He performed a right groin exploration and removed the sheath and guide wire.Fda safety report id # (b)(4).

• Brand Name: STIFFEN MICRO-INTRODUCER KIT 4F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC
• MDR Report Key: 8655010
• MDR Text Key: 146705059
• Report Number: MW5086992
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: 7266V
• Device Catalogue Number: 7266V
• Device Lot Number: 639120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 73 YR
• Patient Weight: 129