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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 double lumen turbo-ject standard power injectable picc line was implanted in a patient for an unspecified indication.The implant approach was not provided.Proper tip placement was verified by radiograph.The physician was not able to aspirate through one of the two lumens while testing the device after placement.A follow-up x-ray showed that the tip of the catheter appeared to migrate or regress cranially and abut against a vessel wall at the level of the trachea.This abutment of the device tip to the vessel prevented aspiration through the catheter tip.The picc line was exchanged during the same procedure and the tip placement confirmed by x-ray the tip extended further caudally than the initial line placement.There are no reported adverse patient consequences associated with this event.The device is not available for evaluation.The product insert that accompanies the device warns the user that "catheter tip position should be monitored by x-ray on a routine basis.Periodic lateral view x-ray is suggested to assess tip location in relation to vessel wall." the insert further cautions that "patient movement can cause catheter tip displacement." the instructions for use also advise "catheter maintenance (.) after catheter placement and prior to use, tip position and lumen patency should be confirmed by free aspiration of venous blood.If blood is not freely aspirated, catheter tip should be immediately reevaluated by physician.".
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering 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: 6547013
• Report Number: 1820334-2017-00935
• Device Sequence Number: 1170992
• Product Code: LJS
• UDI-Device Identifier: 00827002037885
• UDI-Public: (01)00827002037885(17)180819(10)7213088
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2017

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-5.0-CT-NT-1110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 07/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1