• 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 Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
Trackwise id# (b)(4). The lot # 25153605 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 17dec2020. Photographs were provided by the account. Blood was observed on the loading device, as well as the slide lock. Delivery device was shown to be still inside loading device. The seal could be seen inside the loading device, and the seal did not appear to be folded. The cutter was also seen in the photograph with the cap on. The safety lock on the cutter was engaged and the actuation button was not depressed inside the tool. The product was investigated on 28dec2020. A visual inspection was conducted. Signs of clinical use and evidence of blood were observed on the loading and delivery devices. Delivery device was returned inside loading device. The delivery device was removed from the loading device. The tension spring and seal remained inside the loading device. The white plunger on the delivery device remained not pressed in and the blue lock remained in the locked position. The tension spring and seal can be seen inside the loading device the seal was taken out from the loading device for inspection. There was no sign of crack/delamination on the seal. Dimensions of the delivery tube were taken. The inner diameter was measured at 0. 197 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 failure "fitting problem" was confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3. 8mm) separate the loading device tube in the delivery system. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
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 Key11101987
MDR Text Key224793606
Report Number2242352-2020-01150
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 Date09/15/2021
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberC-HSK-3038
Device Lot Number25153605
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received12/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-