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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, CATHETER

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COOK INC FLEXOR RAABE GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KCFW-6.0-38-90-RB-RAABE
Device Problems Device Damaged Prior to Use (2284); Split (2537)
Patient Problem No Patient Involvement (2645)
Event Date 09/01/2016
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
 
Event Description
The reporter said that the tip of sheath was irregular. The returned device revealed that there were splits in the tip of the dilator. This was found prior to use, and there was no patient impact.
 
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Brand NameFLEXOR RAABE GUIDING SHEATH
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6569305
MDR Text Key75440495
Report Number1820334-2017-01124
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002122666
UDI-Public(01)00827002122666(17)190405(10)6866838
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 05/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberKCFW-6.0-38-90-RB-RAABE
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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