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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HS III PROXIMAL SEAL; CLAMP, VASCULAR
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MAQUET CARDIOVASCULAR LLC HS III PROXIMAL SEAL; CLAMP, VASCULAR Back to Search Results
Catalog Number C-HS-3045
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2019
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 was not loaded into the delivery device and it was unable to use.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal was not loaded into the delivery device and it was unable to use.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint # (b)(4).Autonumber # (b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned inside the loading device.The white plunger on the delivery device was not depressed and the blue slide lock was not engaged.The seal was observed in the loading device window.The delivery device was removed from the loading device.The seal remained inside the loading device.The seal was removed from the loading device.No cracks or delamination was observed.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 0.219 in.The length of the delivery tube was measured at 2.51 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¿ is confirmed.
 
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Brand Name
HS III PROXIMAL SEAL
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
MDR Report Key8458083
MDR Text Key140277474
Report Number2242352-2019-00362
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 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/25/2019
Device Catalogue NumberC-HS-3045
Device Lot Number25142365
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2019
Date Manufacturer Received04/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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