MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC VASCBAND; CLAMP VASCULAR

Model Number	3524
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: this complaint is for the second vascband that was applied.Associated with 2134812-2023-00037.Lhc pci was performed access via the right radial artery on an 80 y/o female with fragile skin integrity.A 6f sheath was used in the procedure.Pci procedure did not have any known issues/complications.It was reported that there was a skin tear beside the access area previous to the pci procedure.Post pci procedure, sheath pulled by md.Vascband placed.The patient was transferred from table to stretcher.It was then reported that there was a large hematoma present proximal to the vascband (related to der14601).A second vascband was placed above the first vascband.(related to der14597) hematoma continued to grow.Both bands were removed, and manual pressure was applied.It was reported that the patient's skin tore and caused moderate bleeding.No blood transfusion was required.Vascular surgery was consulted and did a pressure dressing.Wound consult was scheduled for the patient.Additional information.The case was a pci.The hematoma was the size of a tennis ball.There was no visible air leak.The device will not be returned.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.(b)(4) is the supplier for vasc band units.(b)(4) was notified of the complaint.No batch information was provided by the customer.Therefore, manufacturing record review could not be completed.Case details were reviewed.Customer stated "post pci procedure, sheath pulled by md.Vascband placed.The patient was transferred from table to stretcher.It was then reported that there was a large hematoma present proximal to the vascband (related to 2134812-2023-00037).A second vascband was placed above the first vascband.(related to 2134812-2023-00036) hematoma continued to grow.No unit was returned to vsi/teleflex for evaluation.It is unknown if any damages were present on the unit.Additional information was requested.A response was received.Inflation and deflation volume is unknown.Hematoma grew after the first band.A second band was placed.The original skin tear was not at the pci puncture site but was near to it.Both the bands were removed and manual pressure was held.No other procedures were performed aside from dressing the wound.Per ifu, hematoma formation is identified as a potential adverse event that maybe associated with the use of vasc band based on the information and no product evaluation, the most likely root cause of the issue is undeterminable.
Event or Problem Description
It was reported that: this complaint is for the second vascband that was applied.Associated to 2134812-2023-00037.Lhc pci was performed access via the right radial artery on an 80 y/o female with fragile skin integrity.A 6f sheath was used in the procedure.Pci procedure did not have any known issues/complications.It was reported that there was a skin tear beside the access area previous to the pci procedure.Post pci procedure, sheath pulled by md.Vascband placed.The patient was transferred from table to stretcher.It was then reported that there was a large hematoma present proximal to the vascband (related to (b)(4)).A second vascband was placed above the first vascband.(related to (b)(4)) hematoma continued to grow.Both bands were removed, and manual pressure was applied.It was reported that the patient's skin tore and caused moderate bleeding.No blood transfusion was required.Vascular surgery was consulted and did a pressure dressing.Wound consult was scheduled for the patient.Additional information.The case was a pci.The hematoma was the size of a tennis ball.There was no visible air leak.The device will not be returned.

• Brand Name: VASCBAND
• 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: 17541133
• Report Number: 2134812-2023-00036
• Device Sequence Number: 6712850
• Product Code: DXC
• UDI-Device Identifier: 10841156102043
• UDI-Public: 10841156102043
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 3524
• Device Catalogue Number: 3524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/15/2023
• 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
• Patient Age: 80 YR
• Patient Sex: Female