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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER

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COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number MPIS-502-10.0-SC-NT-U-SST
Device Problems Kinked (1339); Material Separation (1562)
Patient Problems Foreign Body In Patient (2687); No Code Available (3191)
Event Date 03/13/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Pma/510(k)
=
k133114. 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 during a venogram with a thrombolysis procedure the wire portion of the micropuncture transitionless stiffened cannula access set met resistance and became kinked upon insertion. During withdrawal of the wire through the sheath, the distal portion of the wire sheared off and was retained in the patient¿s vein. According to information received, the patient had very complicated anatomy which may have contributed to this event. The patient was taken to the operating room where successful removal of the sheared portion was performed. The patient was admitted to the intensive care unit for an unspecified length of time and was subsequently discharged home. According to the initial reporter, the patient did not experience any additional adverse effects due to this occurrence. The initial information was received via user facility report number 1316394638-2018-2 that was emailed to cook inc. By the facility. Additional information was obtained later.
 
Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use, manufacturing instructions, and quality control of the device was conducted during the investigation. The complaint device was not returned; therefore, no physical examinations could be performed. However, a document based investigation evaluation was performed. A review of the device history record shows 3 nonconforming events which could contribute to this failure mode; however, all nonconforming product was scrapped and not replaced. It should be noted there were no other reported complaints for this lot number. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the risk assessment, no further action is required.
 
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Brand NameMICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
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
8123392235
MDR Report Key7420803
MDR Text Key105147920
Report Number1820334-2018-00832
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002355514
UDI-Public(01)00827002355514(17)210131(10)8551936
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMPIS-502-10.0-SC-NT-U-SST
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/31/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/11/2018 Patient Sequence Number: 1
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