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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 Crack (1135)
Patient Problem No Information (3190)
Event Date 05/07/2017
Event Type  malfunction  
Manufacturer Narrative
(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 a coronary artery bypass procedure, hs iii proximal seal looked cracked (looked loosen) in the loader. 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. Signs of clinical use and evidence of blood were observed. Blood was observed on the loading device, delivery tube, and the proximal seal. The delivery device and tension spring assembly were returned inside the loading device. The delivery device was removed from the loading device for inspection. The tension spring assembly remained in the delivery tube with the seal extended partially outside the tube in the pre-deploy state. The slide lock was engaged. The plunger was not depressed on the delivery device. The seal and tension spring was removed from the delivery device for inspection. The seal was observed under microscopy, there was no cracks or delamination observed on the seal. The following measurements were taken; the inner delivery tube diameter was measured at. 197in. The outer diameter was measured at. 220 in. The length of the delivery tube was measured at 2. 50 in. The values recorded were within the tolerance specifications. Based upon the received condition of the device, the reported complaint about reported failure mode ¿crack seal¿ was not confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal looked cracked (looked loosen) in the loader. 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 Key6639895
MDR Text Key77719117
Report Number2242352-2017-00576
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
Type of Report Initial,Followup
Report Date 06/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/09/2017
Device Catalogue NumberC-HS-3045
Device Lot Number25129439
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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