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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 Consequences Or Impact To Patient (2199)
Event Date 02/16/2021
Event Type  malfunction  
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, hst iii seal (4.5mm) was not loaded in the delivery system, so it could not be used.A new device was used as a substitute, and the procedure was completed without any problems.
 
Manufacturer Narrative
Corrected sections: h3, h6 type of investigation - changed from "device not returned" to "testing of actual/suspected device"; h6 investigation findings - changed from "no findings available" to "no device problem found" trackwise # (b)(4).The device was returned for evaluation on 04/19/2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the tip of the delivery device.The delivery device was returned outside the loading device with the seal and tension spring assembly inside the delivery device in an open state.Blood was also observed on the outer part of the intact seal.There were no visual defects observed on the seal.No cracks or delamination was observed on the seal.The white plunger was fully depressed and the blue slide lock was disengaged.The seal and tension spring was removed from the delivery device.No measurements were taken of the delivery device due to the presence of blood which indicates an attempt was made to introduce the device into the aorta.Based on the returned condition of the device, the reported failure "fitting problem" was not confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii seal (4.5mm) was not loaded in the delivery system, so it could not be used.A new device was used as a substitute, and the procedure was completed without any problems.
 
Manufacturer Narrative
Updated sections: g4, g7, h2, h6, h10.Trackwise # (b)(4).The lot # 25151015 history record review was completed.There were ncmrs , rework, or deviations documented for the reported lot number.[ncmr #17080- per 90508578/at and 90520752/aw dunnage product reconciliation form, mcv00052213 and packing list must be attached to each sterile load.Five sterile loads were received at xpo without the dunnage form and packing list attached.Based on the dhr/lhr review results, it was determined that there is a /is no relation between the batch manufacturing process and the reported failure.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii seal (4.5mm) was not loaded in the delivery system, so it could not be used.A new device was used as a substitute, and the procedure was completed without any problems.
 
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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
MDR Report Key11378693
MDR Text Key233541518
Report Number2242352-2021-00179
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700307
UDI-Public00607567700307
Combination Product (y/n)N
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2021
Device Model NumberHST III SEAL (4.5MM), 5-PACK
Device Catalogue NumberC-HS-3045
Device Lot Number25151015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2021
Was the Report Sent to FDA? Yes
Date Manufacturer Received04/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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