MAUDE Adverse Event Report: KEY SURGICAL, LLC VASCULAR LOOPS; SURGICAL VESSEL LOOP

Model Number VL-205

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2023

Event Type  malfunction  

Manufacturer Narrative

The vascular loop subject of the reported event was disposed of and could not be returned to key surgical for evaluation.The device history record was reviewed and confirmed the vascular loop was manufactured to specification.There have been no other complaints associated with this lot.A 3-year complaint review indicates this to be an isolated event.Statements from the instructions for use include, "caution: prior to use visually inspect packaging.Do not use if damaged, opened or breached as sterility cannot be guaranteed.Instructions for use: 1.Remove vascular loops from pouch.2.Remove and discard clip.3.Vascular loops may be single-or double-looped and clamped at the site or may be clamped to vascular surgical drapes." key surgical is not the manufacturer of the rumel tourniquet.Steris notified the manufacturer, becton dickinson, of the reported event to internally investigate and evaluate for reportability in accordance with 21 cfr part 803.Steris evaluated the reported event and determined that it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.Key surgical has offered in-service training on the proper use and operation of the vascular loop; however, the user facility declined.No additional issues have been reported.

Event Description

The user facility reported via medwatch report #4900240000-2023-8024 that when they put their rumel tourniquet on their vascular loop, the vascular loop broke.No report of injury or procedure delay.

• Brand Name: VASCULAR LOOPS
• Type of Device: SURGICAL VESSEL LOOP
• Manufacturer (Section D): KEY SURGICAL, LLC; 8101 wallace road; eden prairie MN 55344
• Manufacturer (Section G): KEY SURGICAL, LLC; 8101 wallace road; eden prairie MN 55344
• Manufacturer Contact: coletta cohara ; 8101 wallace road; eden prairie, MN 55344 ; 4403586251
• MDR Report Key: 16654925
• MDR Text Key: 312544014
• Report Number: 2183785-2023-00001
• Device Sequence Number: 1
• Product Code: KDC
• UDI-Device Identifier: 00849771030874
• UDI-Public: 00849771030874
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VL-205
• Device Lot Number: 136721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1