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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SEAL (4.5MM); CLAMP, VASCULAR
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MAQUET CARDIOVASCULAR LLC HST III SEAL (4.5MM); CLAMP, VASCULAR Back to Search Results
Model Number HST III SEAL (4.5MM), 5-PACK
Device Problems Crack (1135); Premature Activation (1484); Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/24/2020
Event Type  malfunction  
Manufacturer Narrative
Trackwise id # (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.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) seal was bent inside.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
H6 correction: device codes changed to "crack".Internal complaint number: (b)(4).Photographs were provided by the account.A photographic inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was inside the loading device.The loading device was observed to be intact, no visual defects were observed.Due to the positing of the device in the photograph it is unclear if the white plunger is fully depressed or the position of the blue slide lock.The seal was observed in the loading device window.The seal was observed to be in a semi taco shape with no visual defects observed.The device was returned on (b)(6) 2020.An investigation was conducted on (b)(6) 2020.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.The loading device case was observed to be in two pieces indicating break.We are unable to determine when the splitting of the case occurred based on the photographs provided by the account and investigation.The seal and tension spring assembly was observed to be inside the delivery device but not properly loaded.The white plunger was not depressed and the blue slide lock was not dis-engaged.The seal and tension spring assembly was removed from the delivery device.No visual defects, cracks or delamination was observed on the seal.The following measurements of the delivery tube were taken : the inner delivery tube diameter was measured at 0.197 inches, the outer diameter was measured at 0.219 inches.The length of the delivery tube was measured at 2.50 inches.The values recorded were within the tolerance specifications.Based on the returned condition of the device, the reported failure "crack seal" was not confirmed; however, the analyzed failure modes "break" and "fitting problem" were confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii seal (4.5mm) seal was bent inside.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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Brand Name
HST III SEAL (4.5MM)
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
MDR Report Key10063372
MDR Text Key191257115
Report Number2242352-2020-00425
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 05/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/18/2020
Device Model NumberHST III SEAL (4.5MM), 5-PACK
Device Catalogue NumberHS-3045
Device Lot Number25149445
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received06/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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