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 03/07/2022

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

The hospital reported that ultima activator ii reusable drive mech used for coronary artery bypass procedure, shows reddish spots at the transition.The gap is also noticeable, which they find very critical, since impurities can settle here.Complaint before commissioning, therefore no contact with the patient.

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: h3: device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).

Manufacturer Narrative

Trackwise #(b)(4).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)the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period apr 2020 through mar 2022 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 04/06/2022.A photograph was provided by the account.A photographic inspection was conducted.Signs of clinical use and no evidence of blood was observed.There was some discoloration on on the connection part of the jaw and the base of the device.The space was observed as well.There were no other visual defects observed.An investigation was conducted on 04/14/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The device was observed to be intact.There was some discoloration on on the connection part of the jaw and the base of the device.The space was observed as well.There were no other visual defects 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.The dhr, shop floor paperwork is available for review as an attachment to the record.

• 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: 13995113
• MDR Text Key: 288822772
• Report Number: 2242352-2022-00291
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00607567700901
• UDI-Public: 00607567700901
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082725
• 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: 05/13/2022

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: UA-5001
• Device Lot Number: 25162248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 04/06/2022; 05/17/2022
• Supplement Dates FDA Received: 04/28/2022; 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1