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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 Insufficient Information (3190)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/25/2021
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.Device not returned.
 
Event Description
The hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm).They used it as usual, but they couldn't stop bleeding.They opened a new one and was able to use it.There is no problem with the patient.
 
Manufacturer Narrative
Trackwise # (b)(4).Analysis of production: (b)(4) 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.Historical data analysis: ((b)(4)) 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: ((b)(4)) the overall (b)(4) month product complaint trend data for the period (b)(6) 2019 through (b)(6) 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: ((b)(4)) communication/interviews were performed to obtain all possible information.
 
Event Description
N/a.
 
Manufacturer Narrative
Trackwise # (b)(4).Corrected section: h3 device evaluated by mfg changed from "no" to "yes" 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 no evidence of blood was observed.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 visual defects observed on the seal or tension spring assembly.No cracks or delamination was 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 0.220 inches.The length of the delivery tube was measured at 2.50 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device, and no specific failure reported, the analyzed failure "fitting problem" was confirmed.
 
Event Description
N/a.
 
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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 Key12819363
MDR Text Key280810339
Report Number2242352-2021-00956
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
Date FDA Received11/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/13/2022
Device Model NumberHST III SEAL (4.5MM), 5-PACK
Device Catalogue NumberHS-3045
Device Lot Number25158209
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNKNOWN.
Patient Outcome(s) Required Intervention;
Patient SexPrefer Not To Disclose
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