MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; CLAMP, VASCULAR

Model Number VASOVIEW HEMOPRO 2

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device not returned.

Event Description

The hospital reported that during a coronary artery bypass procedure, vasoview hemopro 2 tip of jaw peeled off.Nothing fall into the patient.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise # (b)(4).The lot # 25152740 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.

Event Description

The hospital reported that during a coronary artery bypass procedure, vasoview hemopro 2 tip of jaw peeled off.Nothing fall into the patient.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11313936
• MDR Text Key: 231373840
• Report Number: 2242352-2021-00115
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2022
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25152740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1