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

Catalog Number 82-1707

Device Problem Split (2537)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/03/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been communicated that the device is not available for evaluation.Without the device it is not possible for codman to conduct a proper investigation.Since a lot number has been provided a review of the manufacturing records will be reviewed.We anticipate that the evaluation will reveal that the device conformed to specifications prior to release.If anything otherwise is found then a follow up report will be filed.If at some point the device 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 not available.

Event Description

Reported to (b)(6).Splitting of a 4cm length of a spinal catheter during insertion.This has resulted in the client being left with a foreign body (catheter tubing) in his sub arachnoid space.Clinical records indicate that client was admitted electively for repair of his thoraco abdominal aortic aneurysm.During the admission an attempt was made to insert a spinal catheter.During the procedure a 4 cm length of the catheter sheared off into the sub arachnoid space.Client is currently asymptomatic.Dhb neurosurgical service has advised that the catheter portion should be left in situ with client remaining under observation.Please be aware due to the time difference between (b)(6) versus the u.S.Complaints that are received on the same day that they are entered appear that the complaint created date occurred before the complaint notified date.This is attributed to a system issue associated with the time difference.

• 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: 5151047
• MDR Text Key: 28294867
• Report Number: 1226348-2015-10606
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-1707
• Device Lot Number: 599271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2015
• 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
• Patient Outcome(s): Required Intervention