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U.S. Department of Health and Human Services

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

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MAQUET CARDIOVASCULAR LLC ULTIMA OPCAB SYSTEM, STANDARD BLADE; INSTRUMENTS, SURGICAL, CARDIOVASCULAR Back to Search Results
Catalog Number C-OM-2001S
Device Problems Packaging Problem (3007); Physical Resistance/Sticking (4012)
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.
 
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.
 
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.
 
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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 Key8490955
MDR Text Key141434235
Report Number2242352-2019-00401
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Number of Events Reported1
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 Date08/23/2020
Device Catalogue NumberC-OM-2001S
Device Lot Number25140948
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2019
Initial Date Manufacturer Received 03/13/2019
Initial Date FDA Received04/08/2019
Supplement Dates Manufacturer Received06/18/2019
Supplement Dates FDA Received06/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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