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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	05/17/2017
Type of Reportable Event	Serious Injury
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 patient was undergoing placement of a turbo-ject power injectable for an unspecified indication.The distal portion of the wire guide became "stuck in the soft parts." the clinician was unable to retrieve the device.The device unraveled and a 1cm section of the distal portion of the wire broke, a radiograph confirmed a retained fragment in "the soft parts." an attempt to retrieve the fragment via a skin incision and cut-down was not successful.The fragment remains within the patient.The implant procedure was then performed successfully using a contralateral arm.No further event or patient details were provided; additional information was requested.It is not known if the device is available for evaluation.A follow-up report will be submitted upon receipt of any additional information.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, drawing, instructions for use (ifu), quality control, and specifications was conducted during the investigation, and no issues were found related to the reported issue.The visual inspection of the returned device confirmed that the coil was unraveled at the distal end, starting approximately 105 mm distal to the solder joint with the mandrel.The distal tip of the wire guide was missing, as there was no end weld observed on the distal end of the wire guide.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 turbo-ject power injectable picc set is supplied with the instructions for use which details the warnings, precautions, and instructions for use for proper and safe use of the device.Regarding the access wire guide (stf), the ifu states; after propping the access site, introduce the access needle into the vessel.Note: the use of ultrasound is helpful to determine suitability for vessel access and patency.The echotip marking on the needle is used to help visualize the tip of the needle during vessel access.Using fluoroscopic guidance, introduce the access wire guide through the needle and advance it 15-20 cm into the vessel.Withdraw the needle, leaving wire guide in place.If necessary, enlarge the puncture site with scalpel blade.Based on the information provided, the examination of the returned product, and the results of our investigation, it is possible that the root cause of this event is procedure related.The wire guide getting "stuck in the soft parts" was possibly caused by the patient's anatomy, and that caused the wire guide to unravel.The subsequent retrieval attempt most likely caused the wire guide tip to fracture.However, a definitive root cause could not be determined at this time.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 6659837
• Report Number: 1820334-2017-01409
• Device Sequence Number: 221097
• Product Code: LJS
• UDI-Device Identifier: 00827002561991
• UDI-Public: (01)00827002561991(17)180831(10)7240945
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-4.0-CT-OTW-ST-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 12/21/2017
• 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