MAUDE Adverse Event Report: COOK VASCULAR INC VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT; LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	11/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
Port has been in place for just under 1 month.Patient returned for second chemo treatment and staff could not aspirate blood.Patient sent to x-ray and found that port catheter had separated/broken torn off just below the collar, actually on the catheter and the remaining catheter had traveled into the blood svc and required a further procedure in the hybrid lab to remove the embolized silicone port catheter.This was done via the groin as an emergency procedure.Patient missed their chemo dose and had to have a lengthy endovascular retrieval procedure.The device remained inside the patient body.The patient required another cvad device to be placed so patient could get treatment due to this occurrence.The complainant informed adverse effects on the patient due to this occurrence.However, the complainant does not know how the catheter broke off inside the patient.Only that it did.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, functional testing and visual inspection of the returned device was conducted during the investigation.One used vital port housing and catheter lock were returned for investigation.The catheter was in two pieces; one piece was attached to the port housing and the other piece was inside the snare.The catheter has an ovoid appearance at the fracture.The fragment that remained attached to the port housing was approximately 2.2cm and the larger section of the catheter was 22cm that was folded over with the snare.There was no burnishing or calcification on the catheter surfaces.There were puncture marks evident in the septum and only two of the suture holes were utilized.Several needle marks are visible on the port housing.The catheter lock appears to have been damaged by a sharp tool.There were no occlusions noted in the port or in the catheter when flushed.Radiographic images were also provided.Review of the images noted a pinch of the catheter at the costoclavicular space combined with catheter fatigue.This could have possibly led to the reported fracture.A review of the device history record was conducted.The lot met all release criteria.The instructions for use were reviewed and this is a known failure mode for this device.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.

• Brand Name: VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT
• Common Device Name: LJT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 6200365
• Report Number: 2522007-2016-00014
• Device Sequence Number: 10776207
• Product Code: LJT
• UDI-Device Identifier: 00827002264342
• UDI-Public: (01)00827002264342(17)190228(10)N135440
• Combination Product (Y/N): N
• PMA/510(K) Number: K150733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2016

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-S7010
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2016
• Supplement Report FDA Received Date: 01/23/2017
• 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