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U.S. Department of Health and Human Services

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

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COOK INC FLEXOR BALKIN GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number KCFW-6.0-38-40-RB-BLKN
Device Problems Failure to Advance (2524); Split (2537)
Patient Problem Injury (2348)
Event Date 09/17/2015
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
It was reported that after the vessel puncture, while attempting to advance the introducer into the vessel, the physician noticed the introducer could not pass the puncture site due to the tip being ground/coiled. Visual inspection identified the sheath was also damaged. Device imaging revealed what appears to be a split in the sheath tip. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand NameFLEXOR BALKIN 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 Key6571114
MDR Text Key75439581
Report Number1820334-2017-01158
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002103832
UDI-Public(01)00827002103832(17)140701(10)2783218
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
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-6.0-38-40-RB-BLKN
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 Manufactured07/01/2011
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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