MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW VV6 PRO; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VH-2400
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during an endoscopic vein harvesting procedure, vasoview 6 pro black hair was sealed in the sterile packaging, but because the packaging was reflective, it was not immediately noticeable (you have to look very closely to see it!).Vasoview was used normally/standardly for the procedure.Per photo provided by the complainant, it is observed there is a piece of hair on the plastic tray.
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.
Additional Manufacturer Narrative
(b)(4).The lot # 3000369533 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.H3 other text : device not returned.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise id#: (b)(4).Updated sections: b-4,, g-3, g-6, h-2,h-6, h-11.Corrected section d-9 device available for eval? from "no" to "yes".Corrected section h-3 device evaluated by mfg?: from "no" to "yes", corrected section h-6 type of investigation from "device not returned" to "testing of actual/suspected device".The device was returned to the factory for evaluation on 09/05/2024.Photograph was provided by the account.A photographic inspection was conducted.A portion of the clear plastic device tray is visible, however no device was observed.A hair was observed, however it was unclear whether the hair was inside or outside the tray.An investigation was conducted on 09/17/2024.A visual inspection was conducted.The device was returned inside the opened plastic protective carrier, indicated by the rubber bands holding the two parts together.Signs of clinical use and evidence of blood was observed on the intact device.A hair was observed in the plastic protective carrier.Based on the photographic inspection and as well as the evaluation results, the reported failure "contamination; hair" was not confirmed.

• Brand Name: VASOVIEW VV6 PRO
• Common Device Name: 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 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 19680885
• Report Number: 2242352-2024-00772
• Device Sequence Number: 3212062
• Product Code: GEI
• UDI-Device Identifier: 00607567700239
• UDI-Public: 00607567700239
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K091733
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2024

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: 02/04/2026
• Device Model Number: VH-2400
• Device Catalogue Number: VH-2400
• Device Lot Number: 3000369533
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 08/06/2024; 09/20/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 08/06/2024; 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 85 KG