MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ENDOSCOPIC VESSEL HARVESTING

Model Number C-VH-4000

Device Problem Image Resolution Poor (1306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2015

Event Type  malfunction  

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 dissection tip was clouded.A replacement device was opened and it had etchings on the tip but procedure was completed with this device.The hospital did not report any pt effects.

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.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.It showed signs of clinical usage and no evidence of blood.A visual inspection did not identify any non-conformity.A functional test was conducted on the dissection tip.The device was attached to a reference endoscope.There was clear visibility through the dissection tip, distortion was not observed.We were not able to visualize the reported issue during our evaluation.The reported complaint was unable to be confirmed.(b)(4).

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ENDOSCOPIC VESSEL HARVESTING
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; wayne NJ
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4951758
• MDR Text Key: 22248327
• Report Number: 2242352-2015-00609
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,company representati
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2016
• Device Model Number: C-VH-4000
• Device Lot Number: 25115279
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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: 57 YR
• Patient Weight: 113