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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 Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/17/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 discarded.
 
Event Description
The hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm.Seal loading into the delivery system for use of heartstring iii.When the seal was deployed to the planned anastomosis site, the seal was not fully deployed and the use was discontinued.Ope is finished using the same product of another serial.There was no impact or damage to the patient.
 
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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 07470
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key10610877
MDR Text Key209383952
Report Number2242352-2020-00850
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 company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 09/30/2020
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 Date03/09/2021
Device Model NumberHST III SEAL (4.5MM), 5-PACK
Device Catalogue NumberHS-3045
Device Lot Number25150703
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 09/17/2020
Initial Date FDA Received09/30/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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