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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
Model Number G12266
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Pma/510(k) number: pre-amendment. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that upon opening the package, the tip of the flexor raabe guiding sheath was found to have a "gap". The images provided by the customer showed split-like damage to the distal tip and there was bio-matter present on the device. The complainant confirmed the device never made patient contact. A second flexor raabe guiding sheath was used to complete the unspecified procedure. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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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 (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7550482
MDR Text Key109488437
Report Number1820334-2018-01546
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K142829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/11/2020
Device Model NumberG12266
Device Catalogue NumberKCFW-6.0-38-90-RB-RAABE
Device Lot Number8433429
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 Received03/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2017
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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