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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 Problems Difficult to Insert (1316); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2017
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 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 would not load properly, the seal would not fold or release during use. 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 usage with no evidence of blood were observed. The delivery device was returned inside the loading device. The blue slide lock was engaged and the plunger was not depressed on the delivery device. The seal and tension spring assembly remained inside the loading device. The delivery device was removed from the loading device. The tension spring assembly with the seal was removed from the device for inspection. The seal was observed to be intact, without cracks or delamination. The following measurements of the delivery tube were taken : the inner delivery tube diameter was measured at 0. 197 inches. , the outer diameter was measured at 0. 21 inches. The length of the delivery tube was measured at 2. 50 inches. The values recorded were within the tolerance specifications. Based upon the received condition of the device, and the results of the investigation, the reported complaint for "fitting problem" was confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4. 3 mm would not load properly, the seal would not fold or release during use. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4. 3mm would not load properly, the seal would not fold or release during use. 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
Manufacturer (Section G)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key6564638
MDR Text Key75281754
Report Number2242352-2017-00483
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/11/2018
Device Catalogue NumberC-HSK-3043
Device Lot Number25130317
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/11/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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