MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ULTIMA OPCAB SYSTEM, STANDARD BLADE; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number C-OM-2001S

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(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 been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, ultima opcab system, standard blade remained stuck on the packaging upon opening.A replacement device was used to complete the procedure.No clinical consequences were reported so far.No patient involvement.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, ultima opcab system, standard blade remained stuck on the packaging upon opening.A replacement device was used to complete the procedure.No clinical consequences were reported so far.No patient involvement.

Manufacturer Narrative

Internal complaint # (b)(4).Autonumber # (b)(4).Photos were provided by the complainant.A photographic inspection was conducted.It's observed that a foam piece that is packaged with the devices was stuck to the blister (lid) of packaging.The tray was observed to be empty with no devices.No other observations were observed.The device was returned to the factory for evaluation.Signs of clinical usage and no evidence of blood were observed.A visual inspection was conducted.The blister (lid) was opened upon return of the device.The blade was the only item returned in the tray.There was no evidence that the blade or foam component remained stuck on packaging lid.No failures were observed as the foam is packaged with the devices, the blister (lid) was not compromised in anyway.Based on the returned condition of the device and the results of the investigation the reported complaint "packaging issue" was not confirmed.The shop floor paperwork (dhr) was reviewed.The records show the device lot conformed to all applicable specifications.

• Brand Name: ULTIMA OPCAB SYSTEM, STANDARD BLADE
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8490954
• MDR Text Key: 141432831
• Report Number: 2242352-2019-00402
• 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: 04/05/2019

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 Expiration Date: 05/17/2020
• Device Catalogue Number: C-OM-2001S
• Device Lot Number: 25139176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1