MAUDE Adverse Event Report: MAQUET CV ACROBAT-I STABILIZER; CLAMP, VASCULAR

Catalog Number C-OM-10000

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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.

Event Description

The hospital reported that during a coronary artery bypass procedure using acrobat-i stabilizer.Hospital gradually increased the vacuum pressure to 30kpa, and to 40kpa, but it was unable to vacuum and secure the device.The distributor sales person checked the device connection and no problem was found.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint # (b)(4).Autonumber # (b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure using acrobat-i stabilizer.Hospital gradually increased the vacuum pressure to 30kpa, and to 40kpa, but it was unable to vacuum and secure the device.The distributor sales person checked the device connection and no problem was found.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: ACROBAT-I STABILIZER
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8165543
• MDR Text Key: 130623115
• Report Number: 2242352-2018-01279
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2020
• Device Catalogue Number: C-OM-10000
• Device Lot Number: 25137090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1