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

Model Number	G34513
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the g34513, lot# 9227329 wire in the kit sheared upon removal from the catheter.The portion of the wire that broke off remained in the lumen, and the picc was exchanged via the other lumen.No additional procedures were required.No unintended portion of the device remained inside the patient's body and there were no adverse consequences to the patient as a result of this occurrence.
Additional Manufacturer Narrative
Additional information: d10, e4 investigation - evaluation a review of the complaint history, device history record, drawing, instructions for use, manufacturing instructions, quality control, specifications, as well as a visual inspection and dimensional verification of the returned device was conducted during the investigation.One used catheter manifold assembly and wire guide were returned for investigation.Upon a physical inspection, excessive biomatter was observed on the entire surface.It was noted that the distal tip of the wire guide was separated.No damage could be seen on the catheter manifold.A dimensional analysis confirmed that device components were within the correct specifications and tolerances.The device failure mode was able to be confirmed through table top testing.The catheter was flushed to see if a portion of the wire guide would release.Both hubs initially experienced difficulty being flushed and appeared to have blockages.A representative wire guide was inserted into the hub and the blockage was felt.Destructive testing was performed on the catheter tubing to determine the cause of the blockage.A portion of the wire guide was confirmed to be stuck within the catheter tubing.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record showed no nonconformances for lots 9227329 or ic9168959.It should be noted that there were no other complaints reported for these lot numbers.It was concluded that there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: "this product is intended for use by health care practitioners trained and experienced in proper positioning of catheters in central venous system using percutaneous entry (seldinger) technique.Standard techniques for placement of vascular access sheaths, catheters and wire guides should be employed." catheter placement: (fluoroscopic method) "10.Withdraw the wire guide and¿ 12.Introduce the catheter/obturator assembly into the sheath as far as possible." (non-fluoroscopic method) "6.Leaving the sheath in place, remove the dilator.Note: to prevent inadvertent air aspiration after removing wire guide and dilator, place thumb and forefinger over the proximal end of the sheath.7.Introduce the catheter/obturator assembly into the sheath as far as possible." how supplied "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, examination of the returned product and the results of our investigation, it was determined that procedural errors likely contributed to the failure mode.Device failure analysis confirmed that the distal tip of the wire guide had sheared off and remained in the catheter tubing.According to the instructions for use, the wire guide should not be removed from the catheter manifold assembly.The wire guide is removed after the dilator/sheath combination is placed over it, prior to insertion of the catheter manifold.If the wire guide was removed or maneuvered through the needle during any point of the procedure, it could have contributed to the shearing of the wire.The needle contains a sharp distal end, which could cut the tip of the component.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded no risk reduction activities are required at this time.The appropriate personnel have been notified and we 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 new event description information to report at this time.

• Brand Name: TURBO-JECT® DOUBLE LUMEN 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: 8312714
• Report Number: 1820334-2019-00356
• Device Sequence Number: 16653026
• Product Code: LJS
• UDI-Device Identifier: 00827002345133
• UDI-Public: (01)00827002345133(17)201010(10)9227329
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: 10/10/2020
• Device Model Number: G34513
• Device Catalogue Number: UPICDS-4.0-CT-1111
• Device Lot Number: 9227329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1