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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	04/24/2017
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 catheter for an unspecified indication.The physician was not able to advance the sheath within the patient's left basilic vein during placement.The wire and sheath were exchanged with a competitors product.There is no report of any device malfunction.The customer stated that the patient lost approximately 100cc of blood during the device exchange.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, manufacturing instructions, instructions for use (ifu), and quality control data was conducted during the investigation.The product was returned, but was not available for a detailed inspection.Photos of the device (opened and in used condition) were provided and reviewed.The sheath appeared to have damage at the distal end, at the transition with the dilator.A document-based investigation evaluation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the provided information a definitive root cause cannot be established or reported 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: 6584246
• Report Number: 1820334-2017-01019
• Device Sequence Number: 16165845
• Product Code: LJS
• UDI-Device Identifier: 00827002561991
• UDI-Public: (01)00827002561991(17)180714(10)7118346
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/24/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 01/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention