MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ULTIMA ACTIVATOR II REUSABLE DRIVE MECH; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number ULTIMA ACTIVATOR II REUSABLE DRIVE MECH

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise 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.

Event Description

Related to tw (b)(4).Summary: the hospital reported that during preparation for a coronary artery bypass procedure, ultima activator ii reusable drive mech has pitting corrosion / pitting after 4 weeks of preparation.Mechanical cleaning is carried out with the product thermosept xtra 0.5% from (b)(4).No implantation or use on the patient, but pitting / rust after processing in the washer-disinfector.

Event Description

Related to (b)(4).

Manufacturer Narrative

Trackwise (b)(4).Updated section: g4, g7, h2, h3, h6, h10.Analysis of production: (3331/213/67) the device history records review concluded that 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 manufacturing process and the reported failure mode.Historical data analysis: (4109/213/67) there were 02 additional similar complaint(s) reported for the reported failure mode and the reported serial number.A review of the product complaint trend data was performed for the months of jun 2021¿ through ¿sept 2021.The review does not identify an increasing trend or an adverse trend for three consecutive months for the product family and the failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period oct 2019 through sept 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device : (10 &13 & 22) the device was returned to the factory for evaluation on 11/15/2021.An investigation was conducted on 11/23/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.Evidence of corrosion was observed on the engraved numbers on the device.No other visual defects were observed.Based on the returned condition of the device, the reported failure "corroded" was confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.

Event Description

N/a.

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.Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).

• Brand Name: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 12606233
• MDR Text Key: 278628402
• Report Number: 2242352-2021-00828
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00607567700901
• UDI-Public: 00607567700901
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2021

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
• Device Operator: Health Professional
• Device Model Number: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Device Catalogue Number: C-UA-5001
• Device Lot Number: 25153700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 10/11/2021
• Supplement Dates Manufacturer Received: 11/15/2021; 12/23/2021
• Supplement Dates FDA Received: 11/22/2021; 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1