• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM) CLAMP, VASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM) CLAMP, VASCULAR Back to Search Results
Model Number HST III SYSTEM (3.8MM)
Device Problem Failure to Unfold or Unwrap (1669)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2020
Event Type  malfunction  
Manufacturer Narrative
Trackwise id# (b)(4). The lot # 25153082 history record review was completed. There were no ncmrs, rework, or deviations documented for the reported lot number. Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure. The device was returned to the factory for evaluation on 21dec2020. Photograph from the account shows that the delivery device was seen outside loading device. The tension spring and seal remained inside the loading device. The blue slide lock was dis-engaged and the plunger was completely depressed. Product was investigated on 28dec2020. Signs of clinical use and no evidence of blood were observed. The delivery device was returned outside loading device. The tension spring and seal remained inside the loading device. The blue slide lock was dis-engaged and the plunger was completely depressed. The seal was then pulled out from the loading device for inspection. The seal did not appear to be folded. There was no sign of crack/delamination on the seal. Dimensions of the delivery tube were taken. The inner diameter was measured at 0. 198 inches, the outer diameter was measured at 0. 219 inches (b)(4). The length of the delivery tube was measured at 2. 500 inches (b)(4). The measurement values recorded for the delivery tube were within the tolerance specifications. Based on the returned condition of the device and evaluation results, the reported failures "failure to unfold or unwrap" were not confirmed but the analyzed failure "fitting problem" was confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3. 8mm) seal was properly installed in the tube. There is a phenomenon that you can not fall out. The seal deployed properly and failed to unfold. They tried to install it by forcibly removing the seal, but it could not be used because the seal did not come off, so they used the same new product to finish the operation well. The patient was in good condition and the operation was well completed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHST III SYSTEM (3.8MM)
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 Key11101995
MDR Text Key224794107
Report Number2242352-2020-01149
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeKS
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
Report Date 12/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/19/2021
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberC-HSK-3038
Device Lot Number25153082
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-