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	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); No Code Available (3191)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The international customer reported that, when the vital-port attached silicone catheter with int titanium power injectable port was accessed with a gripped needle and flushed with saline, the patient felt pain and developed redness around the port pocket site.The account reportedly attributed the pain and swelling to the delivery of the saline infusion to an unintended location in the patient's anatomy.The patient was sent to radiology for imaging, and x-rays showed that the port had detached and the catheter was broken approximately 3 cm from the proximal/port chamber end.The interventional radiologist retrieved the broken catheter using a snare, as it was sitting just above the patient's right atrium.The port was removed and returned for evaluation.The device has been received for investigation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Investigation summary: the device was returned and evaluated for this complaint.The engineering and quality engineering department performed a detailed evaluation and found the catheter was returned in two pieces, one smaller fragment that remained attached to the port housing with the lock, and another longer section of catheter.There was evidence of a very slight burnishing on the catheter surfaces near the fractured area, no calcification was present on any surface of the catheters.The areas just behind the fracture had small depressions causing two small nicks.There were puncture marks evident in the septum and it appeared that two of the suture holes were utilized.No needle marks were on the port housing and the catheter lock appeared as a small tear but was received in place.There were no occlusions in the port or in the catheter when flushed.The device history record was reviewed and there are no signs to indicate that this vital port was shipped to the field nonconforming.Per the quality engineering risk assessment (qera), no further action is required.Based on the information provided, the examination of the returned device and the results of the investigation, a definitive root cause could not be determined.

• 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: 7022077
• Report Number: 2522007-2017-00034
• Device Sequence Number: 1851266
• Product Code: LJT
• UDI-Device Identifier: 00827002264380
• UDI-Public: (01)00827002264380(17)200131(10)N143761
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K081425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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-S9010
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR