• 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 SEAL (4.5MM), 5-PACK; 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 SEAL (4.5MM), 5-PACK; CLAMP, VASCULAR Back to Search Results
Model Number HST III SEAL (4.5MM), 5-PACK
Device Problem Insufficient Information (3190)
Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2021
Event Type  Injury  
Manufacturer Narrative
Trackwise id # (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
 
Event Description
The hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm), 5-pack.They used it as usual, but i couldn't stop bleeding.They opened a new one and was able to use it.There is no problem with the patient.
 
Event Description
N/a.
 
Manufacturer Narrative
Trackwise # (b)(4).Corrected section: h6-health effect ¿ clinical code- corrected to -4582.Analysis of production: (3331/213/67) the device history records review concluded that 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 manufacturing process and the reported failure mode.Historical data analysis for similar complaints: (4109/213/67)the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period nov-2019 through oct-2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Device not returned: (4114/67/3221) despite request and/ or customer indicated that the device would be returned; however, no device was returned.
 
Manufacturer Narrative
Trackwise # (b)(4).\ corrected section: h3-if other provide code -explain- device returned.Testing of actual/suspected device: (10/4105/13/22).The device was returned to the factory for evaluation on 03/08/2022.An investigation was conducted on 03/16/2022.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the loading device as well as on the delivery device.The delivery device was returned outside the loading device with the white plunger not depressed and the blue safety lock was on, which prevents the white plunger from being depressed.The seal and tension spring assembly was observed in the loading device.The seal and tension spring assembly was removed from the loading device with no physical or visual difficulties.There were no cracks or delamination observed on the seal.Measurements of the delivery device were taken; the inner diameter was measured at 0.194 inches, the outer diameter was measured at 0.221 inches (rm2036883).The length of the delivery tube was measured at 2.51 inches (mcv00004217).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device, and the no specific failure reported, the analyzed failure "fitting problem" was confirmed.
 
Event Description
N/a.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HST III SEAL (4.5MM), 5-PACK
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ
Manufacturer Contact
arelean guzman
45 barbour pond drive
wayne, NJ 
MDR Report Key12846963
MDR Text Key284462486
Report Number2242352-2021-00972
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 Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/27/2022
Device Model NumberHST III SEAL (4.5MM), 5-PACK
Device Catalogue NumberHS-3045
Device Lot Number25159879
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/28/2021
Initial Date FDA Received11/19/2021
Supplement Dates Manufacturer Received02/03/2022
03/21/2022
Supplement Dates FDA Received02/03/2022
03/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexPrefer Not To Disclose
-
-