MAUDE Adverse Event Report: COOK INC TURBO-JECT® SINGLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	G34521
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a turbo-ject® single lumen over-the-wire power-injectable picc became blocked a day after placement.The line was pulled back 1 cm and flushed successfully.Hours later, the line became blocked again and was unsuccessfully flushed.The picc was removed and replaced the following day with a new device.As reported, the replacement procedure was difficult due to challenging vein access, which left the patient with multiple bruises.The original line was visually inspected and found to have two kinks, one at 9.5 cm and one at 12 cm.
Additional Manufacturer Narrative
Device available for eval: yes; product received on: 06/19/2018.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, specifications,trends and a visual inspection/dimensional verification/functional test of the returned device were conducted during the investigation.Clinical assessment: a kink in the picc line could potentially result in picc line replacement (as in this case) causing major harm.At this time, clinical assessment cannot eliminate any possible causes for this event such as product handling, device maintenance, user technique, device maintenance, medical procedure, device failure, or manufacturing related causes.One device was returned for investigation.The catheter was checked and no kinks were noted, only a very slight indentation found.A wire guide passed through the catheter and through the manifold easily.Additionally, 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 showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is shipped with instruction for use (ifu) which notes: 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.Tip position should appear to be parallel to vessel wall.Based on the information provided, the examination of the returned product, 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.
Event or Problem Description
No new event description information to report at this time.

• Brand Name: TURBO-JECT® SINGLE 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: 7464062
• Report Number: 1820334-2018-01215
• Device Sequence Number: 11131905
• Product Code: LJS
• UDI-Device Identifier: 00827002345218
• UDI-Public: (01)00827002345218(17)200109(10)8499695
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: G34521
• Device Catalogue Number: UPICS-4.0-CT-OTW-ST-1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR