MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEW HEMOPRO 2

Device Problems Stretched (1601); Connection Problem (2900)

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

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise 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 Description

The hospital reported that during preparation for an endoscopic vein harvesting procedure the harvester was preparing to use the vasoview hemopro 2 device to harvest the saphenous vein.During the initial setup, it was noticed that the insufflation tubing on the btt port was stretched /dilated.In addition, the one-way valve at the end of the insufflation tubing would not stay connected to the tubing.Due to this defect, the device was deemed unsafe for use and was removed from the surgical field.The defective device was never used on the patient.A new hemopro 2 kit was opened and the case was finished without any further issues.No complications occurred due to this defect.

Manufacturer Narrative

Trackwise#: (b)(4).The device was returned to the factory for evaluation on 01/13/2023.A photograph was provided by the account.A photographic inspection was conducted.Signs of clinical use and no evidence of blood was observed.The port of the btt was observed to be detached from the tube of the btt.There were no other visual defects observed.An investigation was conducted on 01/30/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The port of the btt was observed to be detached from the tube of the btt.The end of the insufflation tube was observed to be stretched out.There were no other visual defects observed.Based on the photographic inspection, as well as the returned condition of the device as well as the evaluation results, the reported failures "stretched" and "connection problem" were confirmed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The lot # 3000261667 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 failures.

Event Description

N/a.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 16036410
• MDR Text Key: 308280931
• Report Number: 2242352-2022-01040
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

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
• Device Operator: Health Professional
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 3000261667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1