MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEWHEMPRO VH-3500; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEWHEMPRO VH-3500

Device Problems Mechanical Problem (1384); Defective Device (2588)

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

Event Date 01/03/2022

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 an endoscopic vein harvesting procedure using vasoview hemopro vh-3500.They finish their harvest with an endo loop but couldn't use the hole in the c-ring as it didn't go all the way through.They opened another kit so the harvester could thread the c-ring and perform the endo loop.There was no harm to the patient.

Manufacturer Narrative

Trackwise id # (b)(4).Updated section: d-10, g-4, g-7, h-2, h-10, h-11 corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun.".

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that 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 manufacturing process and the reported failure.Correct historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Correct trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period feb-2020 through jan-2022 was reviewed.There were no triggers identified for the review period.Incorrect timeframe entered must mirror trend analysis in investigation record communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Correct testing of actual/suspected device & testing of raw/starting materials: (10 &4105/213/67) the device was returned to the factory for evaluation on 01/27/2022.An investigation was conducted on 02/10/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on both the harvesting device as well as the cannula.There were no visual defects observed on the harvesting device or the cannula.The endoloop hole in the end of the c-ring (metal rod side) was observed to be intact.A needle was utilized to test the hole.It was able to be passed all the way through the endoloop.There were no observed defects.Based on the returned condition of the device and the results of the evaluation, the reported failure "manufacturing, packing, or shipping problem" was not confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.

Event Description

N/a.

Manufacturer Narrative

Trackwise id #(b)(4).Corrected section h6-medical device ¿ problem code: from "1384" to "2588".

• Brand Name: VASOVIEWHEMPRO VH-3500
• 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: 13384591
• MDR Text Key: 284619541
• Report Number: 2242352-2022-00087
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567701250
• UDI-Public: 00607567701250
• Combination Product (y/n): N
• PMA/PMN Number: K153194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/31/2022

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 Expiration Date: 10/25/2022
• Device Model Number: VASOVIEWHEMPRO VH-3500
• Device Catalogue Number: VH-3500
• Device Lot Number: 25160934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 01/27/2022; 02/24/2022; 03/31/2022
• Supplement Dates FDA Received: 02/16/2022; 03/15/2022; 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 101 KG