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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM CLAMP, VASCULAR

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MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3043
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2018
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 seal could not be fixed at the main aortotomy. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
Corrected "aortotomy" to "artery hole" (b)(4). The seal and tension spring assembly were returned to the factory for evaluation. The loading device and delivery device were not returned for investigation. Signs of clinical usage and a speck of blood were observed. A speck of blood was observed on the very end of the coil tip. The seal was observed to be cracked at the outer coil. The tension spring assembly was intact with no defects. No other visual defects were observed. The device as returned was unable to be evaluated for position of seal and tension spring assembly. Measurements of the delivery tube were unable to be taken. Based upon the received condition of the device, the reported complaint for "positioning failure; seal; unable to deploy" was unable to be confirmed, but the analyzed failure mode "crack; seal" was confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system seal could not be fixed at the main artery hole. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
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Brand NameHS III PROXIMAL SEAL SYTEM 4.3MM
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key7709269
MDR Text Key114817037
Report Number2242352-2018-00700
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 07/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/21/2019
Device Catalogue NumberC-HSK-3043
Device Lot Number25137371
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2018
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received09/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

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