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

Catalog Number C-PICS-401J

Device Problem Difficult to Remove (1528)

Patient Problem Surgical procedure, additional (2564)

Event Date 02/19/2015

Event Type  Injury  

Event Description

During a picc placement procedure on a female pt, the guide wire frayed upon removal and become stuck under the skin.The surgeon was called in to remove wire.A section of the device did not remain inside the pt's body.Replacement of the picc line was required.The pt did not experience any adverse effects due to this occurrences.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

• Brand Name: SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SE
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4629698
• MDR Text Key: 5660659
• Report Number: 1820334-2015-00127
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2017
• Device Catalogue Number: C-PICS-401J
• Device Lot Number: 5226231
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/19/2015
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/20/2015
• Initial Date FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2014
• 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): Required Intervention