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	09/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has been contacted for additional information and the sample for evaluation.
Event or Problem Description
Microwire got stuck during seldinger technique and unraveled during removal.A small part of the wire was left inside the soft tissue of the patient's groin.
Additional Manufacturer Narrative
Attempts to obtain additional information about the device and event and to have the sample returned for evaluation were unsuccessful.Without sufficient information, or an evaluation of the device involved, we are unable to determine the cause or factors that may have contributed to this event.

• 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: 8095097
• Report Number: 2518902-2018-00062
• Device Sequence Number: 1902901
• Product Code: DYB
• UDI-Device Identifier: 00884908087666
• UDI-Public: 884908087666
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K130687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: MLMM200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/25/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 05/16/2019
• 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