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

Model Number	G49173
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Turbo-ject over-the-wire single lumen peripherally inserted central venous catheter set.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that the physician punctured the vessel and inserted the sheath as usual for a picc insertion in the patient's right arm.When he attempted to remove the dilator and wire, he felt a little resistance and found the wire had collapsed.The physician removed the wire slowly and carefully, and confirmed no parts of wire remained in the patient's body, then continued with the procedure.
Additional Manufacturer Narrative
Evaluation: a review of the complaint history, 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.The complaint device was returned to cook inc.For evaluation.The wire guide was found to be damaged, elongated, and kinked.The inside diameter of the dilator was found to be within specification.The root cause was found to be likely failure to follow instructions.It was described that the affected access wire guide and dilator were removed together when the event occurred.In the ifu, it states that after the sheath and dilator assembly are introduced over the access wire, the access wire guide is removed and then the longer marked wire guide is inserted.Then, the dilator is removed and the longer, marked, wire guide is left in place to continue the procedure.It is likely that the forces and pressure applied to the access wire guide during removal of the dilator caused the wire to unravel.Use of the more durable, tfe coated, wire guide is recommended and stated in the ifu for use during dilator removal.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information was reported since the submission of the initial report on 05/11/2018.

• Brand Name: TURBO-JECT
• 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: 7507243
• Report Number: 1820334-2018-01453
• Device Sequence Number: 19188755
• Product Code: LJS
• UDI-Device Identifier: 00827002491731
• UDI-Public: (01)00827002491731(17)190118(10)7602678
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K072625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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: G49173
• Device Catalogue Number: UPICS-4.0-CT-OTW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1