MAUDE Adverse Event Report: COOK INC. COOK COPE MANDRIL WIRE GUIDE DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Lot Number 9906161

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/18/2019

Event Type  malfunction  

Event Description

After inserting a temporary dialysis catheter on the left side of the pt's neck, an attempt was made to pull it out, which was common practice, the wire broke off in the pt's subcutaneous tissue.After several attempts, under fluoroscopy, it was deemed unsuccessful.The pt was informed of the incident and given time to discuss and ask questions.

• Brand Name: COOK COPE MANDRIL WIRE GUIDE DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COOK INC. ; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9391810
• MDR Text Key: 168463101
• Report Number: MW5091352
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 9906161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR