MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PERITONEAL CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3045

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain additional information.Upon receipt of new relevant information or completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported by the affiliate that a codman medos peritoneal catheter had migrated after implantation and the device was revised.The valve was implanted; however, date of implant and initial setting are unknown.After implantation, the tip of an abdominal catheter was noted to be in the wrong place, the tip of the catheter had turned to the top.Therefore, the catheter was revised and corrected to the right direction.However, the catheter turned again, in a spiral formation.The surgeon may revise the device again, using a va configuration.The surgeon commented that if the material of the catheter is not changed, this case seems due to patient factors.No further information was provided by hospital.The product will be returned to your site.

Manufacturer Narrative

Corrected fields : device available for evaluation.It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information.Complaint sample was not returned to codman and no product or lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PERITONEAL CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 7822411
• MDR Text Key: 118424239
• Report Number: 1226348-2018-10615
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K944222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-3045
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1