MAUDE Adverse Event Report: COOK VASCULAR INC VITAL-PORT ATTACHED SILICONE CATHETER WITH INTRODUCER SET PLASTIC INFUSION PORT; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/17/2016
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 patient catheter's broke during removal.Ir had to fish it out.The patient's outcome was unknown.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, documentation, manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.One used vital port catheter fragment was received for evaluation.The returned catheter section measured 2.5 cm in length.The port, catheter lock and remaining catheter length were not returned for evaluation.There was tissue attached to the catheter fragment.One end of he catheter fragment had a sharp clean cut and the opposite end of the fragment had a rough appearance.There was calcification on the majority of the catheter od surface.No other holes, nicks, or abrasions were observed on the catheter.Visual inspection confirmed the complaint that the catheter had fractured.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, examination of the returned device 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: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK VASCULAR INC; 1186 montgomery lane; vandergrift PA 15690
• MDR Report Key: 5949102
• Report Number: 2522007-2016-00001
• Device Sequence Number: 18940952
• Product Code: LIT
• UDI-Device Identifier: 00827002265073
• UDI-Public: (01)00827002265073(17)151231(10)N110182
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IP-S5018
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2016
• Supplement Report FDA Received Date: 04/17/2017
• 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