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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 Problems Fitting Problem (2183); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/08/2019
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 been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed.
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proimal seal malfunctioned during loading portion. 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
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key8580874
MDR Text Key144139661
Report Number2242352-2019-00502
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2019
Device Catalogue NumberC-HS-3045
Device Lot Number25141085
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received08/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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