MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VENTRIC. CATH. W/BACTISEAL, STYLET, AND RA ADAPTOR; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3074

Device Problem Kinked (1339)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

After implanting the catheter and connecting it to the shunt system, no fluids were coming out from the distal catheter tip.After few times trying and investigating it found out that the catheter has a kink that was preventing from the fluids to move on.The catheter was replaced with a new one and procedure ended successfully.Did the reported event cause any delays in the procedure or surgery over 30 minutes? no.Were there any adverse consequences to the patient? no.

Manufacturer Narrative

Additional information -- device available for evaluation, date received by mr, type of reports, if follow-up, what type?, additional mfr narrative.The device has been returned for evaluation.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

Upon completion of the investigation it was noted that the catheter was visually inspected: and a knot was noted.The length of these devices are inspected 100% as well as each device is wiped with alcohol.During these operations this type of defect would have been notice and the device rejected.Review of the history device records was not possible as the lot number was unknown.The root cause could not be determined.This problem is not linked to manufacturing process as this type of defect would have been detected during manufacturing process.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: HAKIM VENTRIC. CATH. W/BACTISEAL, STYLET, AND RA ADAPTOR
• 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: 6016390
• MDR Text Key: 56927763
• Report Number: 1226348-2016-10717
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003322
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-3074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2016
• 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