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

Catalog Number	3524
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: customer states "vac band leaking air.Issues with rebleeding, hematoma and vascular surgery." additional information: it was conformed that the issue was with 1 patient and 1 vascband.The patient experienced a hematoma/bleed in the recovery unit post procedure.Vascular surgeon was consulted but it is unknown if the patient returned to surgery.Additional information has been requested from the account.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: customer states "vac band leaking air.Issues with rebleeding, hematoma and vascular surgery." additional information: it was conformed that the issue was with 1 patient and 1 vascband.The patient experienced a hematoma/bleed in the recovery unit post procedure.Vascular surgeon was consulted but it is unknown if the patient returned to surgery.Additional information has been requested from the account.
Additional Manufacturer Narrative
Qn # (b)(4).Complaint verification testing could not be performed as the sample was not returned for analysis.Lepu medical was notified of the complaint.Lepu stated that a dhr could not be provided without lot number.Case details were reviewed.Customer stated "vasc band leaking air.Issues with rebleeding, hematomas and vascular surgery." as no unit was returned to teleflex for evaluation, it was unknown if any damages were present on the unit.As per the additional information received, patient had bleeding and hematoma post procedure.Responses pertaining to the factors such as inflation volume, additional injection of air, steps to achieve hemostasis or additional interventional steps employed to resolve the issue are unknown.A dhr review could not be completed as no lot number was provided by the customer.Based on the limited information, the most likely root cause of the issue is undeterminable.This complaint was scoped to (b)(4) due to trend escalation noted for vasc band leak complaint.The der process will continue to monitor and investigate any similar events.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17816882
• Report Number: 2134812-2023-00047
• Device Sequence Number: 11372586
• Product Code: DXC
• UDI-Device Identifier: 10841156102043
• UDI-Public: 10841156102043
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/30/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3524
• Device Lot Number: UNKNOWN
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/25/2023
• 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