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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Patient code: no known impact or consequence to patient.Device code: break /fractured is not labeled.The event is currently under investigation.
Event or Problem Description
It was reported that during a radiology procedure, a micro-puncture kit that was being used to gain access to the left internal jugular vein, fractured while being used.Fluoroscopic control being used during the procedure confirmed the fracture of the device.The component was in the left internal jugular vein and was positioned over a guide wire.The part attached to the outer hub was removed and the retained part was retrieved from the vessel using a snare wire.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of complaint history, device history record, documentation, specifications and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use, which includes information on intended use, precautions, warnings, potential adverse events, and instructions for proper use of the device.The visual exam of the photo of the complaint device confirms the sheath is severed into two pieces.The distal end of the sheath shows dried biological material and blood.The customer returned one used and separated outer sheath which is a component of the catheter in the complaint device set.The outer sheath was separated 1.5cm from the proximal hub.The distal separated portion was 8.5 cm in length.There was a slight bend in the distal piece.The visual inspection noted there were no other noted surface defects or marks on the distal portion.The separation of the outer sheath showed slight stretching and twisting of the shaft material at the point of separation.There were no other surface defects or marks noted on the proximal hub or connected shaft.Manual tugging confirmed that the shaft was securely connected to the proximal hub.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted that this is the only complaint reported with this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.The returned product was confirmed to have separation/broken attributes on the outer sheath.User technique could have contributed to the failure mode.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
It was reported that during a radiology procedure, a micro-puncture kit that was being used to gain access to the left internal jugular vein, fractured while being used.Fluoroscopic control being used during the procedure confirmed the fracture of the device.The component was in the left internal jugular vein and was positioned over a guide wire.The part attached to the outer hub was removed and the retained part was retrieved from the vessel using a snare wire.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5726034
• Report Number: 1820334-2016-00417
• Device Sequence Number: 13589004
• Product Code: DYB
• UDI-Device Identifier: 00827002562011
• UDI-Public: (01)00827002562011(17)190225(10)6764569
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MPIS-402-NT-U-SST
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2016
• Supplement Report FDA Received Date: 10/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention