MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN EXTERNAL DRAINAGE VENTRICULAR CATHETER SET

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2019

Event Type  malfunction  

Event Description

Complications: codman catheter insertion went in without difficulty but upon withdrawal of guidewire for the catheter, it was difficult to withdraw.The entire catheter was then withdrawn but the tip of the codman catheter was cut along the lumen.During placement of codman lumbar drain catheter a 9 mm fragment broke off after physician attempted to remove catheter from the epidural space.

• Brand Name: CODMAN EXTERNAL DRAINAGE VENTRICULAR CATHETER SET
• Type of Device: EXTERNAL DRAINAGE VENTRICULAR CATHETER SET
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.
• MDR Report Key: 9202815
• MDR Text Key: 162881538
• Report Number: MW5090437
• Device Sequence Number: 1
• Product Code: NHC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 95