MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. ACCU-FLO* CSF RESV 14 MM; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 826100

Device Problem Obstruction of Flow (2423)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

Udi -- (b)(4).Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released.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.

Event Description

It was reported from biomarin, that a patient had an implantation of an intracerebral rickham ventriculostomy (icv) set (codman shurtleff generic icv device).It was noted that the patient experienced a grade 3 icv malfunction (device malfunction).Due to the malfunction, it was not possible to extract cerebrospinal fluid (csf), or to infuse saline.It was reported that the subject¿s catheter had initially been placed in the third ventricle.The catheter had worked for eight infusions; however, during the ninth infusion the reservoir had gone flat and the infusion team was unable to infuse normal saline or obtain a csf sample.The overseeing neurosurgeon decided that the device should be examined under anesthesia in the operating room.The subject was hospitalized and underwent surgery.The neurosurgeon didn¿t find and obstruction or kink in the catheter, but it still wasn¿t functioning either.After moving the catheter to the lateral ventricle, the surgeon was able to obtain a csf sample and infuse again without incidences.It was reported that the surgery went well and the patient was discharged from the hospital within 24 hours.The outcome of the event was updated by the investigator from not recovered/not resolved to recovered/resolved.The investigator reported that it was only the device associated wit the event and not the needle and listed as non-serious.The investigator assessed the event of device malfunction as related to the treatment with bmn 250.

• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• Manufacturer Contact: karen anigbo ; 11 cabot boulevard; mansfield, MA 02048 ; 7819715608
• MDR Report Key: 8340324
• MDR Text Key: 136170625
• Report Number: 1226348-2019-10101
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 826100
• Device Lot Number: 119273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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): Hospitalization; Other
• Patient Age: 4 YR