MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOSHIELD; CATHETER, IRRIGATION

Model Number	VH-5001
Medical Device Problem Code	No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tw id#(b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoshield pressure controlling syringe had no pressure.They used it with a setting of 250mmhg, but since no pressure was applied, they changed the setting to 350mmhg and used it, but still no pressure was applied.The container was filled with water and inspected for leaks.As a result, the blood vessels did not swell and its use was discontinued.No medical/surgical intervention was necessary.They stopped using vh-5001 and used a regular syringe.There were no delays in the process.There were no effects on patient.
Additional Manufacturer Narrative
Trackwise id#: (b)(4).The device was returned to the factory for evaluation on 08/12/2024.An investigation was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the intact returned device.The syringe was filled with 50cc of water to determine if there were any cracks observed.No leaking was observed.The plunger of the syringe was depressed with no physical or visual difficulties observed.Water was expelled from the syringe as the plunger was depressed.Based on the returned condition of the device as well as the evaluation results, the reported failure "no pressure" was not confirmed.The lot # 3000351883 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

• Brand Name: VASOSHIELD
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 19773535
• Report Number: 2242352-2024-00824
• Device Sequence Number: 15492392
• Product Code: GBX
• UDI-Device Identifier: 00607567700468
• UDI-Public: 00607567700468
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: 11/01/2025
• Device Model Number: VH-5001
• Device Catalogue Number: VH-5001
• Device Lot Number: 3000351883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown