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

Model Number	G56194
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the customer returned one stf-18-65-aust wire guide to the manufacturer for investigation.No other device components were returned.Physical examination of the returned device showed: the wire guide was used and in a damaged condition.The distal portion of the device was unraveled and elongated.The solder connections were intact.The weld/solder at the distal tip was not secured.The taper transition was not adequate.Investigators could not recreated the reported failure mode due to the returned condition of the device.Dimensional and visual analysis was performed, but due to the damage and elongation, it could not be determined whether the device had been manufactured out of the correct specifications or tolerances.Investigation: a document-based investigation reviewed the following: drawing, specifications, instructions for use, quality control specifications, manufacturing instructions, complaint history and device history records.A review of relevant manufacturing documents was conducted and determined that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record of the finished product shows no nonconforming events.A complaint history search revealed that there were no other reported complaints for this lot number.Per the ifu: instructions for use: "using fluoroscopic guidance, introduce the access wire guide through the needle and advance it 15-20 cm into the vessel.Withdraw the needle, leaving the wire guide in place.If necessary, enlarge the puncture site with scalpel blade.Introduce the peel-away introducer assembly (sheath and dilator) over the wire guide.With a twisting motion, advance the assembly into the vessel." how supplied: upon removal from package, inspect the product to ensure no damage has occurred.Conclusion: based on the information provided, examination of the returned product, and the results of our investigation, a definitive root cause could not be concluded.However, the possible root causes were determined to be adverse event related to patient condition and procedure.The device became lodged within the anatomy of the patient and required dislodgement with another component.This likely damaged the device, causing the unraveling and elongation of the wire.It is possible that the device became stuck within the vein due to excessive forces experienced during the procedure from either unknown procedural occurrences, or patient anatomy.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints and the appropriate personnel notified.
Event or Problem Description
It was reported the guide wire for insertion of a turbo-ject power injectable urethane peripherally inserted central catheter (picc) became lodged in the patient's basilic vein.As a result, a dilator was inserted over the wire to effectively free the wire from the vein and no harm was reported to the patient.Additional information received indicated the patient did not have tortuous anatomy and a second device was not used for completion of the procedure.Upon inspection of the guide wire by the manufacturer, it was discovered the distal portion of the device was unraveled and elongated.

• Brand Name: TURBO-JECT POWER INJECTABLE
• 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: 8265128
• Report Number: 1820334-2019-00022
• Device Sequence Number: 1500988
• Product Code: LJS
• UDI-Device Identifier: 00827002561946
• UDI-Public: (01)00827002561946(17)200821(10)9109151
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/21/2019

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: 08/21/2020
• Device Model Number: G56194
• Device Catalogue Number: UPICDS-5.0-CT-OTW-ST-1110
• Device Lot Number: 9109151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 70