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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM; CLAMP, VASCULAR

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MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM; CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3038
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2018
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.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, hs iii proximal seal system 3.8mm did not completely roll in the delivery device loading tube.The hospital attempted to manually pull back the delivery device and seal came off midway from the loading device tube.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint number: (b)(4).Autonumber: (b)(4).The device was returned to the factory for evaluation.A visual inspection was performed.Signs of clinical use was observed.There was no evidence of blood detected.The delivery device was returned outside of the loading device, with the tension spring and seal still inside the loading device.The seal is visible through the window of the loading device.The plunger on the delivery device was not pressed and the blue sliding lock was observed to be in the locked position.The seal with the tension spring assembly were pulled out from the loading device for inspection.The tether remained uncut.There were no cracks or delamination detected.The following measurements of the delivery tube were taken: inner delivery tube diameter was measured at 0.197 in., the outer diameter was measured at 0.222 in.The length of the delivery tube was measured at 2.48 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device and the evaluation results, the reported failure ¿fitting problem¿ was confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3.8mm did not completely roll in the delivery device loading tube.The hospital attempted to manually pull back the delivery device and seal came off midway from the loading device tube.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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Brand Name
HS III PROXIMAL SEAL SYTEM 3.8MM
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key8188959
MDR Text Key131333092
Report Number2242352-2018-01347
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 company representative,foreig
Type of Report Initial,Followup
Report Date 12/21/2018
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 Date01/12/2019
Device Catalogue NumberC-HSK-3038
Device Lot Number25136433
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2019
Device AgeYR
Initial Date Manufacturer Received 11/27/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received01/23/2019
Supplement Dates FDA Received01/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age63 YR
Patient Weight57
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