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

Catalog Number 82-1707

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.Device discarded.

Event Description

Physician claim is that the catheter is not visible with imaging.The clinician is questioning whether or not the product is radiopaque.Device discarded.Per rep: "i was really limited in the information that i received.Unfortunately, i can't answer the follow questions with certainty.There was no serial number provided.However, i did receive additional information yesterday that indicated that the patient was over 400lbs and that may have contributed to the inability for the radiologist to see the catheter with x-ray.Apparently, the next patient she attempted to view under x-ray, she had no problem.".

• 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: 6089359
• MDR Text Key: 59506514
• Report Number: 1226348-2016-10779
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-1707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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