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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL; CLAMP, VASCULAR
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MAQUET CV HS III PROXIMAL SEAL; CLAMP, VASCULAR Back to Search Results
Catalog Number C-HS-3045
Device Problems Structural Problem (2506); Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2018
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 didn¿t deploy properly in the patient's aorta.It was also observed that the seal was not rolled well first while preparing the device.A replacement was used to continue the procedure.No patient injury was reported.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal didn¿t deploy properly in the patient's aorta.It was also observed that the seal was not rolled well first while preparing the device.A replacement was used to continue the procedure.No patient injury was reported.
 
Manufacturer Narrative
(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use with evidence of blood were observed.The delivery device was outside the loading device when it was returned.Blood was evident on both components.It was observed that the tension spring assembly remained inside the delivery tube and the seal hanging by the tip of the tube.Blood was all over the delivery device, indicating an attempt to insert the seal into the aorta.The blue lock on the delivery device was disengaged but the white plunger remained un-pressed.The seal which was tainted with blood was observed to be cracked at the center.The tension spring assembly and seal were pulled out from the delivery tube for inspection.The tether remained uncut but detached from the seal.Microscopic inspection of the seal showed cracks at the middle portion but the edges were intact.Based on the returned condition of the device and the evaluation results, the reported failure "fitting problem" was confirmed.The reported failure "activation problem" was not confirmed.The analyzed failure "crack/delaminated seal" was confirmed.
 
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Brand Name
HS III PROXIMAL SEAL
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key7940249
MDR Text Key123205569
Report Number2242352-2018-00978
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2018
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/14/2019
Device Catalogue NumberC-HS-3045
Device Lot Number25137738
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2018
Date Manufacturer Received11/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number0
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