MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC VASC BAND; CLAMP, VASCULAR

Model Number	3524
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the vascband air self-deflating.Hematoma was formed and compression was held.The current patient condition is reported as "fine".Additional information was requested and no information was received regarding medical intervention.
Event or Problem Description
It was reported that: the vascband air self-deflating.Hematoma was formed and compression was held.The current patient condition is reported as "fine".Additional information was requested and no information was received regarding medical intervention.
Additional Manufacturer Narrative
(b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.Lepu was notified of the complaint.Device history record was completed.Case details were reviewed.Customer stated "air self-deflating.Hematoma formed compression held." no unit was returned to vsi/teleflex for evaluation.It is unknown if any damages were present on the unit.Additional information was requested.No response was received.It is unknown how much ml was inflated.Air leak volume is unknown.Per ifu states hematoma formation as a potential adverse event that maybe associated to the use of vasc band.For further investigation, lot review and other testing.

• Brand Name: VASC BAND
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17458148
• Report Number: 2134812-2023-00035
• Device Sequence Number: 19510510
• Product Code: DXC
• UDI-Device Identifier: 10841156102043
• UDI-Public: 10841156102043
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K142359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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 Expiration Date: 03/30/2025
• Device Model Number: 3524
• Device Catalogue Number: 3524
• Device Lot Number: 202303935
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown