MAUDE Adverse Event Report: COOK VASCULAR INC VITAL-PORT ATTACHED SILICONE CATHETER WITH INTRODUCER SET PLASTIC INFUSION PORT; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported after several years of use, the port was removed from the patient because the catheter fractured and broke off in the patient.This event allegedly required transport by ambulance to the (b)(6) emergency room.All pieces were retrieved and the catheter removed.As of the date of this report no additional information is available.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of 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 information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: VITAL-PORT ATTACHED SILICONE CATHETER WITH INTRODUCER SET PLASTIC INFUSION PORT
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 5935718
• Report Number: 1820334-2016-00930
• Device Sequence Number: 385511
• Product Code: LJS
• UDI-Device Identifier: 00827002265110
• UDI-Public: (01)00827002265110(17)150731(10)N107327
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K951077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2016

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: IP-S6018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2016
• Supplement Report FDA Received Date: 03/07/2017
• 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