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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM; SUTURE MEDIATED CLOSURE
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ABBOTT VASCULAR PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM; SUTURE MEDIATED CLOSURE Back to Search Results
Catalog Number 12773-02
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2023
Event Type  malfunction  
Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
 
Event Description
It was reported that when the perclose prostyle device was going to be prepared for the procedure, the outer packaging with the sealed tray inside was unglued.The device was not used.There was no patient involvement.No additional information was provided.
 
Event Description
It was reported that when the perclose prostyle device was going to be prepared for the procedure, the outer packaging with the sealed tray inside was unglued.The device was not used.There was no patient involvement.No additional information was provided.Device analysis revealed a foreign piece of material inside the sealed tray.
 
Manufacturer Narrative
The device was returned for analysis.The reported missing seal was confirmed.A review of the manufacturing records revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported missing seal was concluded to be related to a potential product quality issue.The contamination was concluded to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
 
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Brand Name
PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM
Type of Device
SUTURE MEDIATED CLOSURE
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI  
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key18389107
MDR Text Key331501552
Report Number2024168-2023-14393
Device Sequence Number1
Product Code MGB
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
P960043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number12773-02
Device Lot Number3081441
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/14/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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