MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC VASO VIEW HEMOPRO ; ENDOSCOPIC VESSEL HARVESTING

Model Number C-VH-3000-W

Device Problems Restricted Flow rate (1248); Inflation Problem (1310); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2015

Event Type  malfunction  

Event Description

The hosp reported that during an endoscopic vein harvesting procedure, using the vasoview hemopro, the surgeon complained about an unsatisfactory gas insufflation.According to him, it happened due to failure in the disposable, since they replaced the insufflator, the co2 tank was full, and they tried to use th three way linked to the latex insufflator.Also, he noticed this situation just using the harvest cannula (during the dissection time, the tunnel visualization was perfect, according to him).The team also tried to introduce the co2 through the btt port.The surgeon was able to complete the procedure with the same device.The hosp did not report any pt effects.The surgeon noticed that the insufflation was very low from the moment he started using the cannula tool, and also the btt port wasn't helping to provide an appropriate flow anymore.According to the surgeon, the co2 flow through the cannula wasn't satisfactory.

Manufacturer Narrative

The device has not yet been returned to maquet cardiac surgery for eval.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.(b)(4).

Manufacturer Narrative

A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.(b)(4).

Manufacturer Narrative

The device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.No non-conformities were observed in the visual inspection.The btt was not returned, therefore could not be evaluated.The cannula was evaluated for the presence or absence of air flow through the distal insufflation tube to confirm the reported complaint.A reference endoscope was inserted into the complaint cannula and an air supply was connected to the distal insufflation tubing luer fitting.Air was passed through the insufflation port and was observed to flow freely through the distal port.To verify this, a pouch was sealed over the distal tip of the cannula.Air was passed through the cannula and the pouch was inflated.The air supply was stopped and the pouch stayed inflated.When gentle pressure was applied to the inflated pouch, the pouch remained inflated.The co2 insufflation path on the complaint unit was open and unobstructed.We were unable to reproduce the reported failure in our testing.Based upon these findings, the reported complaint was unable to be confirmed.(b)(4).

• Brand Name: VASO VIEW HEMOPRO
• Type of Device: ENDOSCOPIC VESSEL HARVESTING
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4827143
• MDR Text Key: 5914162
• Report Number: 2242352-2015-00470
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K052274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2015
• Device Model Number: C-VH-3000-W
• Device Lot Number: 25099875
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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
• Patient Age: 66 YR