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 Pitted (1460)

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

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 using ultima activator drive ii, processing of the cs retractor as part of a test by the department for sterile processing of the cssd.It is an old device with massive silicate residues/clear pitting points.The device had already been withdrawn from regular traffic by the cssd! therefore no contact with patients, no use in the operating room.

Manufacturer Narrative

Trackwise # (b)(4).Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period (b)(6) 2019 through (b)(6) 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.Device not returned: (4114, 13, 22):despite request and/ or customer indicated that the device would be returned; however, no device was returned.The device was not returned to maquet cardiac surgery for investigation, however a photograph was provided by the account.A photographic inspection was conducted on (b)(6) 2021.In the photograph there were two images.Image #1 showed some silicate residues/clear pitting points.In image #2, there was no silicate residues/clear pitting points observed.Based on the non-returned condition of the device and the photographic inspection, the reported failure "pitted" was confirmed.The reported device is an oem device, therefore, a lot history review was not applicable.The product is not returning.A serial/lot number was not provided and the specific product serial/ lot number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.

Event Description

N/a.

• 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: 12519062
• MDR Text Key: 272899968
• Report Number: 2242352-2021-00759
• 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
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1