MAUDE Adverse Event Report: COOK INC TURBO-JECT DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	G23905
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 guide wire included in a turbo-ject double lumen over-the-wire power-injectable picc unraveled as the doctor was trying to insert the picc over the wire.The wire unraveled before insertion.Additional information regarding event details has been requested but is not currently available.No adverse effects have been reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.Investigation - evaluation it was reported that a wire guide from a turbo-ject® double lumen over-the-wire power-injectable picc set (upicds-5.0-ct-otw-st-1111) from lot 10206983 unraveled before insertion.The user clarified that when trying to insert the picc over the wire guide, it unraveled.Cook became aware of this event on 20mar2020 upon being notified by royal north shore hospital.The patient reportedly experienced no adverse effects as a result of this incident.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi) 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 master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the design history file (dhf) found that this product is both safe and effective for its intended use.A review of the device history record (dhr) for the reported complaint device lot (10206983) revealed two recorded non-conformances for bent wire guides, in which four devices were scrapped.A database search found no other events associated with the reported device lot.As all nonconforming devices were scrapped, and all remaining devices in the lot underwent quality control activities such as outer diameter gauging, tensile testing, and visual examination for damage.Since these 100% inspection procedures are in place and no other complaints have originated from this lot, there is no evidence that nonconforming product exists in house or in the field.Cook also reviewed product labeling.There is product warning label on the wire guide holder depicting a warning to not pull the distal spring coil portion of the wire guide through the needle tip.The instructions for use (ifu) document for [turbo-ject over-the-wire peripherally inserted central venous catheters] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿precautions ¿ standard technique for placement of vascular sheaths, angiographic catheters and wire guides should employed.Instructions for use 4.Introduce the peel-away introducer assembly (sheath and dilator) over the wire guide.With a twisting motion, advance the assembly into the vessel.(fig.1)¿ based on the information provided, no product returned, and the results of the investigation, it was concluded that the root cause has been traced to a component failure unrelated to manufacturing or design deficiencies.It is possible that the user withdrew the wire through the access needle after placing the wire guide, but this cannot be confirmed with the available information.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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 regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: TURBO-JECT DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC
• 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: 9897354
• Report Number: 1820334-2020-00706
• Device Sequence Number: 11454347
• Product Code: LJS
• UDI-Device Identifier: 00827002239050
• UDI-Public: (01)00827002239050(17)211211(10)10206983
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K132885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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 Expiration Date: 12/11/2021
• Device Model Number: G23905
• Device Catalogue Number: UPICDS-5.0-CT-OTW-ST-1111
• Device Lot Number: 10206983
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1