MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC CODMAN LUMBAR EXTERNAL DRAINAGE KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 82-1706

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/22/2015

Event Type  malfunction  

Event Description

Catheter placed and did not appear to be working.Md attempted to remove and it snapped.Md looked at tip and determined a fragment remained inside patient and was unable to locate or remove.Ct done and verified tip in soft tissue and it was safer for it to remain inside versus removing it.

• Brand Name: CODMAN LUMBAR EXTERNAL DRAINAGE KIT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 5038393
• MDR Text Key: 24368300
• Report Number: 5038393
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/12/2016
• Device Catalogue Number: 82-1706
• Device Lot Number: CMNC1D
• Other Device ID Number: CATH DRAINAGE LUMBAR 46CM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR