MAUDE Adverse Event Report: COOK VASCULAR INC. VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT; NONE

Catalog Number IP-5116-N

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/03/2014

Event Type  Injury  

Event Description

The complaint device was implanted in the patient body for chemotherapy purpose in (b)(6) september 2011 and anticancer agent was injected through the device from then to (b)(6) 2012.Since (b)(6) 2012 the device had not been used, but the periodical flushing of the device with heparin was continued.When radioscopy was conducted on (b)(6) 2014, no problems were observed on the device.However, june 3, 2014 breakage of the catheter and the migration of the broken segment were confirmed.On (b)(6) 2014, the broken segment was retrieved with catheter manipulation and on (b)(6) 2014, the port itself was also retrieved out of the body.Add'l info: (b)(4) 2014.(b)(6) 2011, the port was implanted in left upper arm of the patient for the adjuvant chemotherapy purpose after procedure against colon cancer.(b)(6) 2014, when heparin flushing was performed, resistance was encountered and thus the physician checked the position of the catheter with radioscopy, confirming the breakage and migration of the catheter.The fractured segment of the catheter was in right atrium.(b)(6) 2014, the fractured segment of the catheter was retrieved with catheter manipulation "using a snare" on (b)(6) 2014.

Manufacturer Narrative

(b)(4).Investigation: one mini titanium vital port was rec'd with a catheter lock and two lengths of catheter (~1.5 cm and ~43.5 cm).The 1.5 cm length of catheter was properly attached to the port outlet tube upon receipt.A dimensional verification was performed on the port outlet tube and port catheter.Both components were within acceptance criteria.A visual inspection of the catheter fracture site was performed under magnification.Burnishing was observed on the outer diameter of the catheter.It appears that the suture holes were used.Investigation findings: the presence of burnishing on th od of the catheter indicates long-term wear contributed to the fracture.No info was provided about the device's implantation relative to the brachial vein.There is no evidence of manufacturing nonconformity.

• Brand Name: VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
• Type of Device: NONE
• Manufacturer (Section D): COOK VASCULAR INC.; vandergrift PA 15690
• Manufacturer Contact: brian johnston, reg affairs mgr ; 1186 montgomery lane; vandergrift, PA 15690 ; 7248458621
• MDR Report Key: 3948787
• MDR Text Key: 21527622
• Report Number: 2522007-2014-00009
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IP-5116-N
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2014
• Initial Date FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention