MAUDE Adverse Event Report: DEGANIA SILICONE, INC. VESSEL LOOP BLUE MAXI 2/PK; CLAMP, VASCULAR

Model Number	30-723NS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported that a vessel loop, "snapped during procedure.".
Additional Manufacturer Narrative
A user facility reported that a vessel loop, "snapped during procedure." deroyal industries, inc.Requested return of the device but it was not available.A supplier corrective action request (scar) has been issued to the supplier.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Additional Manufacturer Narrative
A user facility reported that a vessel loop, "snapped during procedure." deroyal industries, inc.Requested return of the device but it was not available.Deroyal reviewed the work order for the lot and found no issues.An inventory check was performed on other lots as no inventory of the reported lot was on hand.Two finished good lots of (b)(4) each and one raw material lot of (b)(4) each were inspected and found to be acceptable.A review of the risk analysis and labeling was also conducted and both were found to be acceptable and no updates were needed.A complaint to sales ratio was conducted over the past two years and found to be (b)(4).A supplier corrective action request (scar) has been issued to the supplier, degania silicone.Degania silicone reviewed the manufacturing and in-process and final packaging inspection records of the reported lot.This review found that the products were manufactured, inspected, and packaged within conformance with the specifications.All parameters were found to be acceptable including tensile strength.Root cause: because the sample was not available for return and no issues could be identified in investigation, the root cause was unable to be determined.Potential root cause: while it is unable to be confirmed, there is a potential root cause that the vessel loop was damaged during use.Because the complaint description stated that the product was stretched, it is possible that this caused damage that caused the vessel loop to tear during the procedure.Corrective and preventive actions: because the root cause was unable to be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: VESSEL LOOP BLUE MAXI 2/PK
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): DEGANIA SILICONE, INC.; 14 thurber blvd.; suite a; smithfield RI 02917
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 22029253
• Report Number: 2320762-2025-00005
• Device Sequence Number: 12792962
• Product Code: DXC
• UDI-Device Identifier: 00749756301312
• UDI-Public: 00749756301312
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K981956
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 30-723NS
• Device Lot Number: 61111177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown