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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR

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MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3038
Device Problem Unraveled Material (1664)
Patient Problem No Information (3190)
Event Date 07/26/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was returned to the factory for evaluation. Signs of clinical use without evidence of blood were observed. The delivery device was returned outside the loading device. The seal and tension spring assembly remained inside the loading device. The blue slide lock was engaged and the white plunger was not depressed on the delivery device. The seal and tension spring assembly was taken out from the loading device for inspection. A microscopic evaluation of the seal and tension spring assembly was conducted. A partial delamination of the seal was observed on the outermost coil. The following measurements were taken; the inner delivery tube diameter was measured at. 197 in. The outer diameter was measured at. 215 in. The length of the delivery tube was measured at 2. 48 in. The values recorded were within the tolerance specifications. Based on the returned condition of the device and the results of the investigation, the reported complaint for "unraveled seal" was not confirmed. The analyzed failure modes "delamination" and "fitting problem" were confirmed.
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system seal unraveled. The hospital did not report any patient effects.
 
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 preparation for a coronary artery bypass procedure, hs iii proximal seal system seal unraveled. The hospital did not report any patient effects.
 
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Brand NameHS III PROXIMAL SEAL SYTEM 3.8MM
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 Key6795407
MDR Text Key248754405
Report Number2242352-2017-00790
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
Report Date 08/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/21/2018
Device Catalogue NumberC-HSK-3038
Device Lot Number25132031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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