MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC MIRA-I CS RETRACTOR BODY; CLAMP-LESS BEATING HEART

Model Number MS-0104

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2015

Event Type  malfunction  

Event Description

The hospital reported that during mvr, mics, the pin of the mira-i cs retractor body stuck out and was about to fall off from rack clamp.A replacement device was used to complete the procedure.The hospital did not report any patient 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.Internal complaint number - (b)(4).

Manufacturer Narrative

The device was returned to the factory for evaluation.It showed no signs of clinical usage or evidence of blood.The pin on the rotating butterfly for the knob was out of place.Device was sent to supplier for further investigation.Supplier conclusion: due to the movement of the pin in one direction coinciding with lack of visible signs of peening on one side, the pin potentially did not receive peening on both sides as required to secure completely.With regular use and applied rotational force, the pin could become loosened to the point where it could protrude from the knob/arbor.Based on the results of the evaluation, the reported complaint was confirmed.The device manufacturer has implemented a corrective action to address the issue.Employees are responsible for the assembly and/or inspection have been re-trained on how to assemble and inspect.A 100 percent inspection will be conducted during assembly and during final inspection.Internal complaint number (b)(4).

• Brand Name: MIRA-I CS RETRACTOR BODY
• Type of Device: CLAMP-LESS BEATING HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4692979
• MDR Text Key: 16073939
• Report Number: 2242352-2015-00303
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,company repres
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS-0104
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2015
• Initial Date FDA Received: 04/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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