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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 Incorrect Measurement (1383); Failure to Unfold or Unwrap (1669); Physical Resistance/Sticking (4012)
Patient Problems Failure to Anastomose (1028); No Consequences Or Impact To Patient (2199)
Event Date 03/11/2019
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 using hs iii proximal seal. They felt substantial resistance while pulling out the proximal seal from the patient¿s aorta after the anastomosis. Hospital continued to pull out the seal little by little and finished the procedure. They had to apply some force to pull the seal, they were concerned about the seal might have been cut off and remained in the aorta. The hospital compared the length of the proximal seal with a new device and found 2cm-difference. (the device in question is shorter than the new one in comparison. ) they are requesting acceptance criteria on the length of the proximal seal. 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 Key8489843
MDR Text Key141313987
Report Number2242352-2019-00387
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/09/2019
Device Catalogue NumberC-HS-3045
Device Lot Number25142077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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