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	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient was undergoing placement of a turbo-ject® double lumen over-the-wire power-injectable picc for an unspecified indication.The guide wire unraveled and 'has fallen apart' during placement.The wire was exchanged for a new device.The procedure was completed without further incident.No further patient or event information was provided.The device is reportedly available for evaluation, however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
Additional information: a second wire guide was used in the procedure; however, it also unraveled.This event has been reported under mw# 1820334-2017-04162.Investigation - evaluation: a review of dimensional verification, complaint history, device history record, documentation, drawings, instructions for use(ifu), manufacturing instructions, specifications, quality control data and visual inspection of the returned device was conducted during the investigation.Visual inspection and functional testing of the returned device were performed.It appeared to be an uncoated wire and was unraveled at the solder joint approximately 59 cm from the proximal end of the wire guide.The distal weld was still intact with the coils but the mandril was not attached.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 would contribute to this failure mode.There were no other reported complaints for this lot number.The ifu instructs to withdraw the provided needle before withdrawing the wire guide.The customer stated the wire had been withdrawn through the 21g needle in the picc kit.Based on the information provided, examination of the returned product, and the results of our investigation; the root cause was determined to be product use/handling related- did not follow instructions/label, as the customer did not follow instructions and withdrew the wire guide through the needle.We have notified the appropriate personnel and will continue to monitor for similar events.

• 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: 6667137
• Report Number: 1820334-2017-01072
• Device Sequence Number: 19347869
• Product Code: LJS
• UDI-Device Identifier: 00827002345164
• UDI-Public: (01)00827002345164(17)180817(10)7157854
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K132334
• 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): 12/08/2017

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: UPICDS-4.0-CT-OTW-ST-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1