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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SYSTEM (4.5MM), 5-PACK CLAMP, VASCULAR

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MAQUET CARDIOVASCULAR LLC HSK III SYSTEM (4.5MM), 5-PACK CLAMP, VASCULAR Back to Search Results
Model Number HST III SYSTEM (4.5MM), 5-PACK
Device Problem Failure to Unfold or Unwrap (1669)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative
Trackwise id #: (b)(4). Since the device is not available to be returned to us, a technical evaluation cannot be performed. Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii seal (4. 5mm), 5-pack ,a repeat full sternotomy approach was used, exposing the anterior wall of the ascending aorta. Epiaortic ultrasound revealed that the aortic wall was severely calcified and therefore unclampable; however, a clear site for proximal anastomosis was identified on the right side of the aorta. Avoiding calcified sites, a small hole was created with a heartstringvr aortic cutter (size; 4. 3 mm), and a heartstring proximal seal system delivered into it. However, effective haemostasis was not achieved. The device was therefore removed and an aortic cannula mounted by a 14-mmprosthetic vascular graft in advance was inserted into the hole. A purse string suture was placed with a tourniquet, and then tied down.
 
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Brand NameHSK III SYSTEM (4.5MM), 5-PACK
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
dorota wolpiuk
45 barbour pond drive
wayne, NJ 07470
MDR Report Key10788276
MDR Text Key214753237
Report Number2242352-2020-00955
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700307
UDI-Public00607567700307
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHST III SYSTEM (4.5MM), 5-PACK
Device Catalogue NumberHS-3045
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received11/17/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/04/2020 Patient Sequence Number: 1
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