MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; MINOR VASCULAR

Model Number	DYNJ902890B
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during a left carotid endarterectomy the vessel loop was positioned around the distal and proximal carotid.When the surgeon was about to insert the argyle shunt into the distal portion of the carotid, the vessel loop suddenly broke and caused approximately 50ml of blood loss.Another vessel loop was opened and placed around the distal portion of the carotid.The surgeon proceeded with the case without further incident.The sample is available and has been requested to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, 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 vessel loop broke and cause blood loss during the procedure.
Additional Manufacturer Narrative
Sample received 10/15/2021.The sample was returned for evaluation and the customer reported issue of the vessel loop breaking was confirmed.The root cause could not be determined.No additional information is available.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: MINOR VASCULAR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12636955
• Report Number: 1423395-2021-00052
• Device Sequence Number: 19745574
• Product Code: OEZ
• UDI-Device Identifier: 10888277796546
• UDI-Public: 10888277796546
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 10/21/2021

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: DYNJ902890B
• Device Catalogue Number: DYNJ902890B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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: 83 YR
• Patient Weight: 82