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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 Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2018
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 4. 3mm umbrella was not released. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4). The device was returned to the factory for evaluation. A visual inspection was conducted. Signs of clinical use and evidence of blood were observed on the tension spring assembly and on the seal. No other part or component of the device was returned. The seal appeared intact, unfolded and with no signs of cracks nor delamination. The seal was tainted with blood which indicates an attempt for deployment. Based on the returned condition of the device and the evaluation results, the reported failure ¿positioning failure; unable to deploy¿ was not confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4. 3mm umbrella was not released. 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 Key7742162
MDR Text Key115943352
Report Number2242352-2018-00732
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 08/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/17/2019
Device Catalogue NumberC-HSK-3043
Device Lot Number25136529
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 Received09/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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