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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2017
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 standard power injectable picc line.The customer reports that "the patient vein condition was not good and tortuous." the physician had difficulty inserting the wire guide but was not able to insert the catheter.The physician removed the wire guide and observed that the soft tip of the wire was broken.The physician was not able to use the picc line.No adverse patient consequences are reported.The device was received for evaluation.No unintended section of the device remained within the patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of documentation, complaint history, device history record, manufacturing instructions, visual inspection, specification, instructions for use (ifu) and quality control data was conducted during the investigation.The device set is supplied with two different wire guides, one short wire for gaining access and a longer marked wire for guiding the catheter into the target vessel.The customer did not specify which wire contributed to this complaint.An evaluation of the ifu was performed.The ifu states the intended use, warnings, precautions, product recommendations, and instructions for proper use.Wire guide was manufactured according to specified dimensions and the bill of materials.The wire guide was inspected per quality control procedures, including a torque test, verification of solder joints, and inspection of the distal tip.The device history record was reviewed and there were no non-conformances found to be related to the failure mode in this event.To date, a search of complaint records revealed this complaint to be the only reported complaint associated with the complaint lot number.Two wires were returned for investigation.The associated catheter was also returned and has been evaluated in separate complaint record (b)(4).During the investigation, it was observed that there were multiple kinks located towards the distal end on the coiled section.The transition zones between mandril and coiled wire were smooth.The tip weld is intact.No section of the wire is missing or broken.The wire dimensions were found to be in specification.The access wire (shorter length) was also returned used and damaged.There are multiple kinks located towards the distal end on the coiled section.The transition zones between mandril and coiled wire were smooth.The tip weld is intact.No section of the wire is missing or broken.The wire dimensions were found to be in specification.Based on the investigation and the reported tortuous anatomy, it is probable that kinking was caused by the patient anatomy.The reported 'soft tip was broken' cannot be confirmed as neither wire guide appears broken or separated in any way.The initial report that the catheter could not be introduced over the wire could be a result of the distal end kinking.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the risk assessment no further action is required.

• 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: 6585080
• Report Number: 1820334-2017-01267
• Device Sequence Number: 91797
• Product Code: LJS
• UDI-Device Identifier: 00827002037861
• UDI-Public: (01)00827002037861(17)180705(10)7094675
• Combination Product (Y/N): N
• 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): 08/29/2017

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: UPICS-5.0-CT-OTW-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1