MAUDE Adverse Event Report: MEDCOMP 5F REG MICRO-STICK NIT WIRE KT; INTRODUCER

Model Number	MR190521
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
While attempting to gain access to the right internal jugular vein experienced wire and introducer needle miscommunication.The wire and needle became twisted together and difficult to separate.Multiple unsuccessful attempts were made to separate the two by advancing and pull back on the wire to free it from the needle.In an attempt to remove the wire and the needle out of the body simultaneously the tip of the wire broke and began to unravel.Several attempts were made to retrieve the remaining 1.0 to 1.5 cm portion of wire.Ultimately it was decided that it was safer to leave it in the patient's chest wall.The patient was transferred to pacu in satisfactory condition.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.A picture of an x-ray was provided and confirmed the tip of the guidewire is knotted inside the body.Without an evaluation of the device we are unable to determine the root cause and if a manufacturing issue was present.The report indicated that "multiple unsuccessful attempts were made to separate the two (guidewire and needle) by advancing and pull back on the wire to free it from the needle." this technique may have caused the tip of the wire to loop over itself and become knotted preventing removal and ultimately causing the wire to break and unravel.This is well documented in the literature.

• Brand Name: 5F REG MICRO-STICK NIT WIRE KT
• Common Device Name: INTRODUCER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7885744
• Report Number: 2518902-2018-00049
• Device Sequence Number: 11221920
• Product Code: DYB
• UDI-Device Identifier: 00884908087666
• UDI-Public: 884908087666
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/29/2023
• Device Model Number: MR190521
• Device Catalogue Number: MR190521
• Device Lot Number: MLJC500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention