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	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/16/2017
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® single lumen over-the-wire power-injectable picc.The wire guide became stuck as the physician attempted to push the guide through the venipuncture needle.The needle was removed to aid in the unsuccessful removal of the guide wire.The puncture site was 'gently' enlarged with a scalpel.The wire was successfully removed after approximately 10 minutes of minor manipulation.A new catheter could not be placed because the patients' vessels collapsed.No further information was provided.The device is anticipated to be returned for evaluation.
Additional Manufacturer Narrative
Corrected information: changed from product problem to adverse event and product problem.Type of reportable event was changed from malfunction to serious injury.Investigation ¿ evaluation a review of dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, specifications, quality control data, and visual inspection of returned product was conducted during the investigation.Visual and functional inspection of the returned device was performed.The measurements and observations recorded during device failure analysis were within specification; however, the distal weld was absent from the returned, damaged wire.The distal weld failure may be related to patient anatomy, disease state or condition, or handling and use related, but cannot be definitively determined.A document-based investigation evaluation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record shows no nonconforming events which could contribute to this failure mode.A review of complaint history search revealed that there were no other reported complaints for this lot number.The instructions for use (ifu) provides instruction in the appropriate use of the over-the-wire catheter.The device is supplied with a caution label which illustrates; "withdrawal and/or manipulation of the distal spring coil portion of the wire guide through the needle tip may result in breakage.¿ based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6705357
• Report Number: 1820334-2017-01623
• Device Sequence Number: 1723800
• Product Code: LJS
• UDI-Device Identifier: 00827002345218
• UDI-Public: (01)00827002345218(17)190415(10)7834360
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2017

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?: Yes
• 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: 06/16/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 10/09/2017
• 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
• Patient Weight: 87