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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HS III PROXIMAL SEAL SYTEM 3.8MM; CLAMP, VASCULAR
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HS III PROXIMAL SEAL SYTEM 3.8MM; CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3038
Device Problems Detachment Of Device Component (1104); Uncoiled (1659)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2018
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 an endoscopic vein harvesting procedure, hs iii proximal seal system 3.8mm partially detached and uncoiled in the device before it was removed.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.A visual inspection was conducted.Signs of clinical use and no evidence of blood were observed.The delivery device was returned inside the loading device.The blue slide lock was engaged and the white plunger was not depressed on the delivery device.The seal was observed in the loading device window, no visual defects were observed on the seal.The delivery device was removed from the loading device for inspection.The seal and the tension spring assembly remained inside the loading device.No deformities were observed on the delivery tube.The tension spring assembly and the seal were then pulled out from the loading device for inspection.The seal was observed to have slight crack in the center of the seal.The following measurements of the delivery tube were taken: inner delivery tube diameter was measured at 0.198 in., the outer diameter was measured at 0.219 in.The length of the delivery tube was measured at 2.50 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based upon the received condition of the device, and the results of the evaluation, the reported failure mode "fitting problem" and "cracked seal" were confirmed.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure, hs iii proximal seal system 3.8mm partially detached and uncoiled in the device before it was removed.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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Brand Name
HS III PROXIMAL SEAL SYTEM 3.8MM
Type of Device
CLAMP, VASCULAR
MDR Report Key7471938
MDR Text Key107120660
Report Number2242352-2018-00404
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/20/2018
Device Catalogue NumberC-HSK-3038
Device Lot Number25135012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2018
Device Age YR
Date Manufacturer Received06/13/2018
Patient Sequence Number1
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