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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR STARCLOSE VASCULAR CLOSURE SYSTEM; VESSEL CLOSURE CLIP
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ABBOTT VASCULAR STARCLOSE VASCULAR CLOSURE SYSTEM; VESSEL CLOSURE CLIP Back to Search Results
Catalog Number 14679-02
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 02/06/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that during unpacking of a starclose se device, it was observed that the sterile packaging pouch was not totally sealed.There was no patient involvement and the device was not used.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported ¿sterile packaging pouch was not totally sealed¿ was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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Brand Name
STARCLOSE VASCULAR CLOSURE SYSTEM
Type of Device
VESSEL CLOSURE CLIP
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key9806314
MDR Text Key182601883
Report Number2024168-2020-02157
Device Sequence Number1
Product Code MGB
Combination Product (y/n)N
PMA/PMN Number
P050007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2021
Device Catalogue Number14679-02
Device Lot Number9102241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Date Manufacturer Received04/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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