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

Model Number	VH-5001
Medical Device Problem Codes	Inflation Problem (1310); Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
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 vessel harvesting procedure, vasoshield pressure controlling syringe set at a pressure of 250 did not cause blood vessels to swell.A new device was used to successfully complete the procedure.
Additional Manufacturer Narrative
Tw # (b)(4).Updated sections: b4,b5,d9,g3,g6,h2,h3,h10,h11.Corrected section: h6- clinical code changed to 4582; impact code changed to 2199.
Event or Problem Description
The hospital reported that during an endoscopic vessel harvesting procedure, vasoshield pressure controlling syringe set at a pressure of 250 did not cause blood vessels to swell.The pressure was raised to 350mmhg.The container was filled with water and used as usual.Harvesters have were not able to confirm a leak.A new device was used to successfully complete the procedure without further medical or surgical intervention.There was no procedural delay.There was no patient harm.
Additional Manufacturer Narrative
Trackwise#: (b)(4).Corrected sections: h6: medical device ¿ problem code corrected from "1310" to "2954".The device was returned to the factory for evaluation on 06/05/2024.An investigation was conducted on 06/12/2024.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the intact syringe.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 "improper flow or infusion" was not confirmed.The lot #3000284604 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.
Event or Problem Description
The hospital reported that during an endoscopic vessel harvesting procedure, vasoshield pressure controlling syringe set at a pressure of 250 did not cause blood vessels to swell.The pressure was raised to 350 mmhg.It was difficult to get enough pressure out of the syringe.Nothing ever came out of the syringe.The container was filled with water and used as usual.Harvesters have were not able to confirm a leak.A new device was used to successfully complete the procedure without further medical or surgical intervention.There was no procedural delay.There was no patient harm.

• 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
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 19340595
• Report Number: 2242352-2024-00535
• Device Sequence Number: 20615699
• 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,Followup
• Report Date (Section B): 07/08/2024

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: 12/07/2024
• Device Model Number: VH-5001
• Device Catalogue Number: VH-5001
• Device Lot Number: 3000284604
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 05/20/2024; 07/17/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/11/2024; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown