MAUDE Adverse Event Report: COOK INC VITAL-PORT ATTACHED SILICONE CATHETER WITH INTRODUCER SET PLASTIC INFUSION PORT; LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); 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 that a catheter; which was inserted on (b)(6) 2013 at the right internal jugular (ij) vein, fractured during removal.The patient was transferred by ambulance, from the surgery center to another hospital to have the fragment removed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.One used ip-s6018 vital port was received for evaluation along with a catheter lock and one catheter fragment.The approx.10.5 cm length of catheter was attached to the vital port body along with the catheter lock.No other catheter fragments were received with this complaint.Visual inspection confirmed that the catheter fractured.Visual inspection of the fracture site could not confirm the presence of burnishing.There is no evidence that any part of the catheter was cut with a sharp surgical tool.Calcification was seen on the outer surface of the catheters fragments.The suture holes were used, approximately 3 marks/nicks from a needle on the top of the vital port body were noted; no other holes, nicks, or abrasions were observed on the outlet tube or the catheter.A document based investigation evaluation was also 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, examination of the returned device and the results of our investigation, product use or handling associated with operational or environmental context caused or contributed to the event.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: LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5983815
• Report Number: 2522007-2016-00004
• Device Sequence Number: 510570
• Product Code: LJT
• UDI-Device Identifier: 00827002265110
• UDI-Public: (01)00827002265110(17)160229(10)N111844
• 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
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2017

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?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 04/19/2017
• 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: Other