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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT¿; STENT, CAROTID

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BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT¿; STENT, CAROTID Back to Search Results
Model Number H965SCH647080
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Date 10/04/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported that product sterility was compromised.An 8.0-29 carotid wallstent¿ was selected for use.However, during unpacking, it was noticed that the inner packaging was slightly opened.The device was never used in the patient.No patient complications were reported.
 
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Brand Name
CAROTID WALLSTENT¿
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6976090
MDR Text Key90856568
Report Number2134265-2017-10368
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P050019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/11/2020
Device Model NumberH965SCH647080
Device Catalogue NumberSCH-64708
Device Lot Number20518158
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/05/2017
Initial Date FDA Received10/25/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2017
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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