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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SEAL (4.5MM), 5-PACK; CLAMP, VASCULAR

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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 Fitting Problem (2183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2022
Event Type  malfunction  
Manufacturer Narrative
Trackwise id (b)(6).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 the hst iii seal (4.5mm), 5-pack seal development did not go well.The seal could not be loaded into the delivery tube and remained in the loader and could not be deployed.The white plunger is not pressed because the seal could not be deployed when loading it into the delivery device.The blue slide is still locked and not unlocked.The new product was opened and the ope was successfully completed.The patient has no health hazards.
 
Manufacturer Narrative
Trackwise # (b)(4).The lot 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.H3 other text : device not returned.
 
Event Description
N/a.
 
Event Description
N/a.
 
Manufacturer Narrative
Trackwise # (b)(4).Corrected section: h4- if other provide code -explain- device returned, h6 -investigation findings (1) removed code "3221" and replaced it to "13"- device returned, h6 -type of investigation removed code " 4114- device returned, d10- device available for eval- device returned.The device was returned to the factory for evaluation on 03/23/2023, however, the product was brought to the lab on 05/17/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned inside the loading device with the white plunger not depressed and the blue safety on, which prevents the white plunger from being depressed.The seal and tension spring assembly was observed in the loading device window.A mechanical evaluation was conducted.The delivery device was removed from the loading device with no visual or physical difficulties observed.The seal and tension spring assembly remained inside the loading device.The seal and tension spring assembly was removed from the loading device with no visual or physical difficulties observed.The seal was observed to be unraveled at the center of the seal and detached from the tension spring assembly.No other visual defects were observed.Measurements of the delivery device were taken; the inner diameter was measured at 1.97inches, the outer diameter was measured at 0.220 inches ((b)(4)).The length of the delivery tube was measured at 2.49 inches ((b)(4)).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device as well as the evaluation results, the reported failure "fitting problem" was confirmed, and the analyzed failures "unraveled seal" and "detachment of device or device component"" was observed.The lot #25159879 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.
 
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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 Key15592070
MDR Text Key305546364
Report Number2242352-2022-00859
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,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/18/2023
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 Date08/27/2022
Device Model NumberHST III SEAL (4.5MM), 5-PACK
Device Catalogue NumberC-HS-3045
Device Lot Number25159879
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/22/2022
Initial Date FDA Received10/12/2022
Supplement Dates Manufacturer Received11/30/2022
05/19/2023
Supplement Dates FDA Received11/30/2022
05/19/2023
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 SexPrefer Not To Disclose
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