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 has been received for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Investigation summary: a review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use, specifications, manufacturing instructions, and quality controls were completed, and visual inspection of the returned device was conducted during the investigation.The manufacturing documents in place at the time of manufacture were reviewed ad it was found that the device aspects in question were visually inspected by quality control.The risk specification for this product includes the failure mode of unraveling and identifies that multiple risk controls are in place to mitigate the risk of this failure mode.The device history record for the lot number was reviewed.No related non-conformances were identified.A search of our complaint records indicates that this is the only complaint on the lot number at the time of the investigation.The product was returned and appeared to have unraveled.Measurements of the component in question were performed on the wire, and it was found that the device was manufactured to specification.The root cause of this complaint is due to product use/handling related - did not follow instructions/label, as the customer did not follow instructions and withdrew the wire guide through the needle.The risk analysis for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.We have notified the appropriate personnel and 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: 7062733
• Report Number: 1820334-2017-04162
• Device Sequence Number: 16174571
• 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): 12/07/2017

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: 10/31/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 11/28/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1