MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN LUMBER CATHETER KIT; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-1707

Device Problem Difficult To Position (1467)

Patient Problem No Information (3190)

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

The catheter is difficult to place.When the cathter is removed, it may break or tear.No clinical incident for the patient.

Manufacturer Narrative

The catheter was returned and evaluated.A review of manufacturing records was performed and found that the device met specification when released to sterilization.The catheter was visually inspected and exhibited signs of obvious damage extending from the first row of holes distally.This type of damage is often seen when a catheter is inserted and then subsequently retracted.The sharp tip of the trocar can, on rare occasions, get caught in the distal holes.As the catheter is further extracted, the catheter is torn by the sharp end of the trocar.A portion of the distal catheter appears to be missing.The amount of catheter present on the returned part is insufficient to recreate an entire distal section.The following warning is included in the product insert to avoid this type of event from occurring: "to avoid damage to the catheter, care must be taken not to withdraw the catheter from the needle in order to reposition it in the subarachnoid space.If the catheter must be removed, withdraw the needle and catheter simultaneously." based on the evaluation of the device, the damage to the catheter was caused by retraction of the catheter after insertion without simultaneously retracting the needle, which is explained within the product insert.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: CODMAN LUMBER CATHETER KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5247138
• MDR Text Key: 32099322
• Report Number: 1226348-2015-10703
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK964923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-1707
• Device Lot Number: 635925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• 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