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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PROTEGE RX; CAROTID STENT

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COVIDIEN PROTEGE RX; CAROTID STENT Back to Search Results
Model Number SECX-10-7-40-135
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Patient Involvement (2645)
Event Date 10/21/2014
Event Type  malfunction  
Event Description
During demonstration at the hospital, the physician confirmed the size of the protege stent was smaller than its specification; the diameter was the same as (b)(4).The physician rubbed and soaked it in hot water to see if the size changed; however, the stent remained the smaller size.Event occurred during a product demonstration, no patient involvement.
 
Manufacturer Narrative
Evaluation of the images and returned device confirmed that the stent labeled 7x10x40mm was 8x6x40mm.(b)(4).
 
Manufacturer Narrative
This supplemental mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.Additional correction.
 
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Brand Name
PROTEGE RX
Type of Device
CAROTID STENT
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
stephanie riley
4600 nathan lane n
plymouth, MN 55442
7633987000
MDR Report Key4601367
MDR Text Key5468609
Report Number2183870-2015-00070
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P060001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,company representati
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/23/2014
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 Date06/04/2016
Device Model NumberSECX-10-7-40-135
Device Catalogue NumberSECX-10-7-40-135
Device Lot Number9922452
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2014
Is the Reporter a Health Professional? No
Event Location Nursing Home
Initial Date Manufacturer Received 10/23/2014
Initial Date FDA Received03/13/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received10/29/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0878-2015
Patient Sequence Number1
Patient Outcome(s) Other;
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