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

Model Number ULTIMA ACTIVATOR II REUSABLE DRIVE MECH

Device Problem Corroded (1131)

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

Event Date 07/29/2021

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

The hospital reported that during preparation for a coronary artery bypass procedure, ultima activator ii reusable drive mech has pitting corrosion / pitting after 7 reprocessing cycles mechanical cleaning is carried out with the product thermosept xtra 0.5% from schülke.No implantation or use on the patient, but pitting / rust after processing in the washer-disinfector.The retractor has been replaced and is in the hospital as a consignment from uwe tausch.

Event Description

N/a.

Manufacturer Narrative

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

Manufacturer Narrative

Internal complaint number: (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.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaint 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 sept 2019 through aug 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 09/15/2021.An investigation was conducted on 10/13/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The engraved maquet was observed to be a rust color as well as on the engraved # =200501.Based on the returned condition of the device, the reported failure " corroded" was confirmed.

Event Description

N/a.

• Brand Name: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• MDR Report Key: 12346587
• MDR Text Key: 268916985
• Report Number: 2242352-2021-00681
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00607567700901
• UDI-Public: 00607567700901
• 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,Followup
• Report Date: 10/19/2021

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: 25157489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 09/15/2021; 10/20/2021
• Supplement Dates FDA Received: 10/11/2021; 10/20/2021
• Patient Sequence Number: 1