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

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that while positioning the picc line during a placement procedure, the wire guide of a turbo-ject standard power injectable picc line picc became stuck in the needle introducer.Several withdrawal attempts were made but resulted in the wire guide fraying and breaking.Once the needle introducer was completely removed, the distal extremity of the wire guide was found to be stuck in the needle introducer.A scope was performed on the patient to confirm that no piece of the wire guide remained inside.No adverse effects as a consequence of this event have been reported.Additional information regarding event details has been requested but is unavailable at the time of this report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Correction: d6 - implant date.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d10 - product received on.Investigation evaluation.A review of the documentation including the complaint history, device history record (dhr), drawing, instruction for use (ifu), manufacturing instructions (mi), quality control and specifications, as well as a visual inspection of the returned device was conducted during the investigation.One damaged wire guide was returned to cook for investigation.A visual inspection of the device revealed the wire guide to be elongated on the distal end.No distal end weld ball was present.Additionally, a document-based investigation evaluation was performed.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device's design history files (dhf) were reviewed, and the risks associated with these devices are acceptable when weighed against the benefits.All tested devices met the acceptance criterion for ensuring that the needle lumens for representative access needles are compatible with appropriately sized wire guides.A review of the dhr for the complaint lot (9492772) and subassembly lots (ic9410717 and ic9348143) revealed no non-conformances.A database search found no additional complaints related to the complaint lot.As there are adequate inspection activities established, objective evidence that the dhr was fully executed, no non-conformances, and no additional complaints from the same lot, cook has concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: instructions for use: after prepping the access site, introduce the access needle into the vessel.¿ using fluoroscopic guidance, introduce the wire guide through the needle and advance it 15-20 cm into the vessel.¿ ¿withdraw the needle, leaving wire guide in place.If necessary, enlarge the puncture side with scalpel blade.¿ how supplied¿ ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ the complaint was able to be confirmed based on evaluation of the returned device along with customer testimony.Based on the information provided, inspection of the returned product, and the results of our investigation, a definitive root cause can be traced to the user's failure to follow instructions.The customer stated that they attempted to remove the wire guide from the introducer needle, which the warning label cautions against.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor 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 regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: TURBO-JECT STANDARD POWER INJECTABLE PICC LINE 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: 9158281
• Report Number: 1820334-2019-02541
• Device Sequence Number: 2164643
• Product Code: LJS
• UDI-Device Identifier: 00827002037779
• UDI-Public: (01)00827002037779(17)210202(10)9492772
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2019

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: 02/02/2021
• Device Model Number: N/A
• Device Catalogue Number: UPICS-4.0-CT-NT-1110
• Device Lot Number: 9492772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/04/2019; 11/21/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 10/04/2019; 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1