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

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.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Type of Device: DYB 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 Key: 7420803
• MDR Text Key: 105147920
• Report Number: 1820334-2018-00832
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002355514
• UDI-Public: (01)00827002355514(17)210131(10)8551936
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• 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 Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MPIS-502-10.0-SC-NT-U-SST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Date Device Manufactured: 01/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 72