MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. BACTISEAL CL EVD 1.9 CATHETER SET; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-1750

Device Problem Fracture (1260)

Patient Problem Swelling (2091)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During craniotomy, an evd was placed.The patient had swelling on the right side of face following surgery.After it was removed by the neurosurgeon, he found it to be fractured.No patient harm reported.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.A review of manufacturing records found no discrepancies when the device was released to stock.The catheter was fractured between the 2nd and 3rd markers.The fracture was about two thirds of the way through the tube.No obvious signs of abuse or mishandling.Fracture has a zig-zag pattern.The remainder of the catheter is free of defects; no other areas are showing signs of any deterioration.The complaint has been confirmed that the catheter has a fracture.No root cause could be determined.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: BACTISEAL CL EVD 1.9 CATHETER SET
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5924399
• MDR Text Key: 53800791
• Report Number: 1226348-2016-10620
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 82-1750
• Device Lot Number: C14289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 83 YR