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	N/A
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/04/2018
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
The international customer reported that the patient's turbo-ject® single lumen over-the-wire power-injectable picc (peripherally inserted central catheter) after one week implantation into the right basilic vein, the picc line was difficult to flush.The patient's chemotherapy treatments were supposed to infuse over 48 hours, but they took 72 hours to infuse.Increased difficulty with flushing the line was reported and the infusion rate continued to worsen over time.There was an external kink in the line noted, and once the patient's dressings were taken down and their securacath was removed, the line was even more difficult to flush.The patient had the picc line implanted for about a month.As a result of the issues experienced, the device was removed from the patient and new picc line placed.Once the line was removed, multiple kinks in the line which had been internal to the patient were visible.Once the device was removed it flushed easily.The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Additional information: concomitant medical products.Corrected data: date of event.Investigation: evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, and specifications as well as a visual inspection and functional evaluation of the device was conducted during the investigation.One device was returned for investigation.The returned catheter length is 43 cm.The visual inspection of the returned device confirmed the presence of kinks at distances of 33 cm, 35.5 cm, 42 cm, and 43 cm from the distal tip of the device.A leak test was performed, and no leaks were noted.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.Ifu t_ctpiccotwtt_rev1 instructions for use: warnings: verify: prior to use that the maximum pressure limit is set at or below 325 psi and that the maximum flow rate is at or below that which is listed on the catheter.Precautions if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Catheter size should be as small as the use will allow.Catheter tip positioning.Every effort must be made to ascertain proper tip position in order to prevent erosion or perforation of the central venous system and to ensure proper delivery of infusates.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.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.

• 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: 7284873
• Report Number: 1820334-2018-00236
• Device Sequence Number: 1475349
• Product Code: LJS
• UDI-Device Identifier: 00827002345218
• UDI-Public: (01)00827002345218(17)190811(10)8133528
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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: N/A
• Device Catalogue Number: UPICS-4.0-CT-OTW-ST-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 05/10/2018
• 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 Weight: 100