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

Model Number	G56194
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 while guiding the wire to the target vessel, the tip lodged itself in a small branch.While pulling the wire back, the wire was felt to be elongating.After three hours the wire was retrieved with a 5fr brite tip sheath coaxially with a 2.6fr cxi catheter.The procedure was completed successfully.The devices and their components were examined after removal and the "spring-like" wire tip was visually confirmed to be elongated/unwound.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
A review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The reported used device was returned to cook inc.For evaluation.The length of the unraveled coil was 50.5 cm long.The coil was not separated.There was a kink located at approximately 18.5 cm from the distal end of the device (not including the unraveled portion).There was mandril separation.Measurements could not be taken for comparison as the wire was received in a severely damaged and elongated condition.A root cause is unable to be determined.Potentially patient anatomy, manufacturing errors, user technique, etc.Could have contributed to this event.In addition, separation most likely caused the difficulty experienced during retraction of the wire guide.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no notable gaps in production or processing controls were noted.The device history record for lot number 8199415 was reviewed.No non-conformances related to the reported failure mode were noted.A search of our complaint records indicates one similar complaint from the same lot.This failure will continue to be trended, however, at this time, there is no indication from the device history record that there is nonconforming product in the field.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 06/14/2018.

• Brand Name: TURBO-JECT POWER INJECTABLE
• 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: 7600332
• Report Number: 1820334-2018-01719
• Device Sequence Number: 16550215
• Product Code: LJS
• UDI-Device Identifier: 00827002561946
• UDI-Public: (01)00827002561946(17)191016(10)8297294
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K111244
• 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): 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: G56194
• Device Catalogue Number: UPICDS-5.0-CT-OTW-ST-1110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 06/14/2018
• 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