MAUDE Adverse Event Report: SCANLAN INTERNATIONAL INC. SCANLAN® MULTI-PURPOSE CLAMP; MEDIUM VASCULAR CLAMP

Model Number	2002-16
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Reperfusion Injury (4851)
Date of Event	02/12/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The instrument in question was not returned for further analysis, and no further information was made available by the reporting institution.Review of the design, manufacturing batch record, and technical documentation show that there were no non-conformities, no history of reportable events, and no relevant complaints.No root cause can be identified for this occurrence from the information available.This reported occurrence appears to be an anomaly.
Event or Problem Description
During a cardiovascular surgery (ascending aorta surgery and aortic valve plasty), the aortic clamp broke at the level of one of the two jaws, causing an unexpected reperfusion of a vascular sector containing air and thus threatening the patients vital prognosis.Unfortunately, the patient died.

• Brand Name: SCANLAN® MULTI-PURPOSE CLAMP
• Common Device Name: MEDIUM VASCULAR CLAMP
• Manufacturer (Section D): SCANLAN INTERNATIONAL INC.; one scanaln plaza; saint paul MN 55107 1629
• Manufacturer (Section G): SCANLAN INTERNATIONAL; one scanlan plaza; saint paul MN 55107 1629
• Manufacturer Contact: mark watson ; one scanlan plaza; saint paul, MN 55107-1629 ; 6517285759
• MDR Report Key: 18960893
• Report Number: 2126670-2024-00001
• Device Sequence Number: 15224998
• Product Code: DXC
• UDI-Device Identifier: 00846159007442
• UDI-Public: 00846159007442
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2002-16
• Device Catalogue Number: 2002-16
• Device Lot Number: AH3C1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown