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	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
Product code: ljt subcutaneous, implanted, intravascular infusion port and catheter.Investigation result - one used vital port was returned with this complaint.Engineering performed an evaluation and found that the returned vital-port was covered with calcification, which potentially could have led to difficulties during the removal process.The catheter was returned in 6 pieces ranging from 1 to 8 cm in length.A few of the mating surfaces exhibited signs of being cut with a sharp surgical instrument.Others had a matte finish and likely failed during removal due to the calcification growth along the length of the catheter.A review of complaint history, device history records, documentation, manufacturing instructions (mi), quality control(qc) measures and specifications were conducted, as well as a visual inspection of the returned product.A full dimensional measurement could not be completed as the catheter was in several sections.A review of manufacturing records were reviewed and all processes were complete and approved by trained personal.There were no nonconformances issued during the manufacturing process of this lot.After review, no signs were found to indicate that nonconforming product was released to the field.No other complaints have been filed for this device lot.We will continue to monitor for similar events.Per risk assessment documentation, no other actions are required at this time.

• 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: 5938770
• Report Number: 1820334-2016-00928
• Device Sequence Number: 13760646
• Product Code: LJT
• UDI-Device Identifier: 00827002265110
• UDI-Public: (01)00827002265110(17)151031(10)N109077
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• 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?: Yes
• 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: 09/09/2016
• Supplement Report FDA Received Date: 01/26/2017
• 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