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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 Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was returned to the factory for evaluation. Signs of clinical use and evidence of blood were observed. The loading device was not returned to the factory for evaluation. A visual inspection was conducted. The delivery device was observed to be covered in blood. The white plunger was fully depressed on the delivery device. The blue slide lock was disengaged. The tension spring assembly remained in the delivery tube with the seal extended and hanging outside the delivery tube completely unfolded. The seal and tension spring were removed from the delivery tube for inspection. Microscopic inspection determined that the seal, though tainted with blood, was intact, with no cracks or delamination. Blood was visible in the delivery device indicating that there was attempt to deploy the device into the aorta. Based on the received condition of the device, we were not able to measure the delivery tube dimensions. Based on the returned condition of the device, it was apparent that the seal was properly loaded. The reported failure mode "fitting problem" was therefore not confirmed.
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal was not loaded into the delivery system properly. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint number trackwise # (b)(4). A lot history record review was completed for the reported product lot number. There was no nonconformance recorded in the lot history. 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 proximal seal was not loaded into the delivery system properly. 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 CV
45 barbour pond drive
wayne NJ 07470
Manufacturer (Section G)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key6926920
MDR Text Key247545127
Report Number2242352-2017-00947
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/19/2018
Device Catalogue NumberC-HS-3045
Device Lot Number25131990
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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