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

Model Number	G26511
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).Event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of investigation.
Event or Problem Description
It was reported that an infusion port was implanted into the patient (b)(6) 2017.When patient came back to the hospital for treatment, the nursing staff could not get blood return upon accessing the device.A scan was performed and it was discovered that the port was cracked, causing the patient to undergo an additional procedure for the successful reinsertion of another device.No additional patient consequences were reported.
Additional Manufacturer Narrative
Investigation summary: the affected device was not returned for this complaint.No photos or x-rays were provided.A physical investigation could not be performed by the quality engineering departments since the product was not returned.This complaint will be logged and tracked in the complaint handling and post market surveillance processes.The device handling record was completed, including the manufacturing and quality control activities.There are no signs in the device handling record to indicate that this device was shipped to the field nonconforming.The device was not returned and therefore a determination if the device was defective is inconclusive and the complaint could not be confirmed, since no other information was provided.

• 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 VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 7205288
• Report Number: 2522007-2018-00003
• Device Sequence Number: 11017001
• Product Code: LJT
• UDI-Device Identifier: 00827002265110
• UDI-Public: (01)00827002265110(17)190531(10)N138186
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K951077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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: G26511
• Device Catalogue Number: IP-S6018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 05/22/2018
• 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