MAUDE Adverse Event Report: COOK INC TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a central line was being placed for antibiotic treatment; however, when attempting to remove the guide-wire to place the line, the wire unraveled and/or knotted and could not be removed.Surgery was performed to remove the wire from the patient.The patient was in stable condition and was referred to another facility to have a central line placed.
Additional Manufacturer Narrative
Product has been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported that a central line was being placed for antibiotic treatment; however, when attempting to remove the guide-wire to place the line, the wire unraveled and/or knotted and could not be removed.Surgery was performed to remove the wire from the patient.The patient was in stable condition and was referred to another facility to have a central line placed.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, dimensional verification, instructions for use (ifu), device history record, manufacturing instructions, specifications, trends, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: contraindications, warnings, precautions, and instructions for use.The visual inspection of the returned device reported that the distal weld connection separated from the inner mandril wire, resulting in the coil becoming elongated and mandril becoming exposed.This type of device failure has generally been associated with the wire guide being damaged by withdrawal and/or manipulated through the needle (see warning label) or other instrument.Less frequently, patient anatomy makes withdrawal of the wire guide difficult resulting in damage when the force exceeds design specification.Nevertheless, the appropriate individuals have been notified.The remaining sets were examined and confirmed to be manufactured to current specification.The complaint device was returned therefore, an investigation evaluation was performed.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 there were no other reported complaints for this lot number.Based on the information provided, and the results of our investigation, a definitive root cause could not be determined.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 a central line was being placed for antibiotic treatment; however, when attempting to remove the guide-wire to place the line, the wire unraveled and/or knotted and could not be removed.Surgery was performed to remove the wire from the patient.The patient was in stable condition and was referred to another facility to have a central line placed.

• Brand Name: TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5852954
• Report Number: 1820334-2016-00779
• Device Sequence Number: 19142804
• Product Code: LJS
• UDI-Device Identifier: 00827002128019
• UDI-Public: (01)00827002128019(17)190517(10)6977507
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K041849
• 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,Followup
• Report Date (Section B): 07/25/2016

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: UPICS-501-MPIS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/25/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/08/2016
• Supplement Report FDA Received Date: 11/08/2016; 11/11/2016
• 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
• Patient Weight: 79