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

Catalog Number UA-5001

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 sanitization and sterilization using ultima activator ii reusable drive mech, it was rinsed 1 x prior to the test op after delivery (not sterile) and rust was present on the obstruction.No patient involvement.

Event Description

The hospital reported that during sanitization and sterilization using ultima activator ii reusable drive mech, it was rinsed 1 x prior to the test op after delivery (not sterile) and rust was present on the obstruction.No patient involvement.

Manufacturer Narrative

Corrected section: h6 - device code changed to corrosion.Trackwise # (b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use with no evidence of blood were observed.Brown spots can be observed along the drive mechanism which appears to be rust or corrosion.It was also observed that the trade name maquet engraved on the device appeared brown resembling rust or corrosion.Based on the returned condition of the device, the reported failure corrosion was confirmed.

• 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 07470
• MDR Report Key: 8642911
• MDR Text Key: 146231325
• Report Number: 2242352-2019-00599
• Device Sequence Number: 1
• Product Code: DWS
• 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
• Report Date: 05/23/2019

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 Catalogue Number: UA-5001
• Device Lot Number: 25142110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/25/2019
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1