MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 4F STIFF MICRO-STICK NIT WIRE KIT; MICRO-STICK INTRODUCER

Model Number	DMR190411
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.We are currently waiting for additional information and the return of the device for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
As guidewire was threaded through the needle, wire frayed and could not be retracted completely.The wire required open incision for removal.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.Requests for additional information and device return were not successful.The device contract manufacturer conducted a review of the manufacturer records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.Without an evaluation of the device a root cause cannot be determined.The instructions for use (ifu) contains the following warnings and precautions: do not advance the guidewire against resistance until the cause of the resistance has been determined.Do not insert or withdraw the guidewire forcibly from any component.The wire may break or unravel.If the guidewire becomes damaged, the introducer needle or sheath dilator and guidewire must be removed together.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4F STIFF MICRO-STICK NIT WIRE KIT
• Common Device Name: MICRO-STICK INTRODUCER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 16673880
• Report Number: 2518902-2023-00028
• Device Sequence Number: 20138600
• Product Code: DYB
• UDI-Device Identifier: 00884908142440
• UDI-Public: 00884908142440
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K091954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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 Model Number: DMR190411
• Device Catalogue Number: DMR190411
• Device Lot Number: MQNB210
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White