MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; MICRO PUNCTURE 5FR STIFF NT/TG E

Model Number	DYNJMAST10
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that, during an endo avf creation procedure, the guidewire broke off into the patient as the physician was attempting to access the patient's medial brachial vein.When the break was identified, the physician held onto the external part of the broken guidewire and was able to successfully retrieve the piece from the patient.No adverse patient impact occurred and there was no further medical intervention or follow-up care related to the incident.No sample was returned for evaluation.A root cause could not be determined at this time.Due to the reported need for medical intervention to retrieve the broken guidewire piece, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the guidewire component broke.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: MICRO PUNCTURE 5FR STIFF NT/TG E
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12444142
• Report Number: 3004122598-2021-00001
• Device Sequence Number: 3350345
• Product Code: OEZ
• UDI-Device Identifier: 10888277586222
• UDI-Public: 10888277586222
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

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: Health Professional
• Device Model Number: DYNJMAST10
• Device Catalogue Number: DYNJMAST10
• Device Lot Number: 21DBQ058
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/08/2021
• 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
• Patient Age: 58 YR