MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problems Edema (1820); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The user facility report stated that, on an unknown date following implantation, the peripherally inserted central catheter (picc; specific product information not known) broke under the patient's skin while implanted in the patient.The patient was initially admitted to the hospital to receive treatment for cancer.During their stay, the picc line was inserted by the anesthesia department.The patient was transferred to a local hospital a few days later for additional treatment.The picc line was then used for parenteral nutrition as well as iv fluid.After a few days of use, the line could not longer be flushed, so a specialized team which was trained to handle picc lines was brought in to inspect the device.The insertion point and integrity of the catheter were both examined, and no issues were noted.Mild pressure was then used to flush the catheter, and after a few attempts, free flow was achieved, and blood could be aspirated thereon.The following day, the patient's arm was noted to have become extremely edematous.The patient was placed under observation, and all intravenous fluid an medicine was paused while the patient was examined for possible deep vein thrombosis; this was later ruled out.It was decided that the picc line would be removed however, so this was done under the guidance of the picc line team.During the removal of the line, it was discovered that the picc line had broken inside the patient; the line had almost completely broken off, although the catheter was able to be removed without a complete separation of the broken portion.All pieces of the device were accordingly recovered from the patient.The reason for the break is not known.Additional information was obtained from the department acknowledging that high pressure was used on the catheter.The catheter photographs indicate this is a silicone catheter and not approved for high pressure.The fact the catheter was not approved for high pressure was not given to the hospital where the patient was transferred.Additional information has been requested from the customer, but none has yet been received.The device is reportedly unavailable for return.

Manufacturer Narrative

Correction: report date: correction from 02/08/2018 to 02/27/2018.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the documentation, quality control, specifications and photographic inspection was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a photo of the complaint device was received and a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Clinical assessment: the potential effect related to the picc separation is embolization possibly resulting in severe harm (harm resulting in life-threatening illness or injury).There are many unanswered questions regarding the device, securing the device, device maintenance, and intended use for this particular patient.The department physician states the facility used high pressure and should not have.It is not certain if the device will be returned for evaluation.Therefore, based the statements from the facility, the most probable cause of this event is use error related.However, device maintenance/care and device failure related factors cannot be entirely ruled out the lot number of the device is not known; accordingly, a review of the device history record and complaint search on lot number could not be conducted.Based on the information provided, no product returned and the results of our investigation, the most probable cause of this event is use error related.Per the quality engineering risk assessment, no further action is required.

• Brand Name: SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7301512
• MDR Text Key: 101113959
• Report Number: 1820334-2018-00407
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K950118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PICS-501J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention