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

Catalog Number C-OM-10000

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Internal complaint number trackwise # (b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer malfunctioned and was not clicking.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the entire device.No visual defects were observed.The device was evaluated for its mechanical function.The device was securely assembled onto a reference retractor blade by sliding the stabilizer base onto the rail and locking the lever.The device was unable to moved when the locking lever was engaged.The knob was evaluated for its ability to tighten the flexlink arm while the locking lever was in both the locked and unlocked positions.The flexlink arm was secured in position when the knob was turned clockwise.No audible clicking noise was observed.Based upon these findings, the reported complaint for the reported failure mode "mechanical issue" was not confirmed.

Event Description

The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer malfunctioned and was not clicking.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: STABILIZER,HEART
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 7383654
• MDR Text Key: 104036898
• Report Number: 2242352-2018-00280
• Device Sequence Number: 1
• Product Code: MWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2019
• Device Catalogue Number: C-OM-10000
• Device Lot Number: 25134532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1