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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that while attempting to place the piccline arterial catheter in the paediatric intensive care unit, there was difficulty in getting the wire guide through the needle.The device was gently pulled back out by the physician, the wire guide was reinforced but still encountered resistance.The decision was made to completely remove the wire guide, which came out completely frayed.A new placement completed with another catheter from the same lot encountered no issues.There were no negative consequences for the patient.Additional information has been requested but not provided by the reporter.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.A visual examination of the supplied mandril guide discovered that the distal solder connection has separated from the inner mandril wire, resulting in extreme coil elongation.Approximately 1.0cm of the coil located at the most distal end was not elongated.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 description of the event and the fact that there was no obvious defect regarding to manufacturing to the wire guide, it is possible that the wire guide tip caught on the introducing needle and force beyond design requirements were used to remove the guide.Affixed to the wire guide protective shipping tube is a caution label that pictorially cautions against the reverse process of withdrawing the wire guide in the needle as damage may occur.We can also advise that manipulation of the wire through the needle may cause damage to the coil.Patient anatomy may make withdrawal or manipulation of the wire guide difficult resulting in damage when the force exceeds design specification.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 while attempting to place the picc line arterial catheter in the paediatric intensive care unit, there was difficulty in getting the wire guide through the needle.The device was gently pulled back out by the physician, the wire guide was reinforced but still encountered resistance.The decision was made to completely remove the wire guide, which came out completely frayed.A new placement completed with another catheter from the same lot encountered no issues.There were no negative consequences for the patient.Additional information has been requested but not provided by the reporter.

• Brand Name: TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED 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: 5843839
• Report Number: 1820334-2016-00701
• Device Sequence Number: 446838
• Product Code: LJS
• UDI-Device Identifier: 00827002558830
• UDI-Public: (01)00827002558830(17)180217(10)6743163
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-3.0-CT-NT-1110
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1