MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD VENT RES TR SAL-RIC ST BA; RESERVOIRS

Catalog Number	821625
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 1 of 2 reports linked to mfg report numbers: 3013886523-2024-00100.Medwatch (b)(4).Study: 9 year-old female participant.Biomarin study: cerliponase alfa observational study."the participant's past medical history included anaemia, hordeolum and covid-19.The participant's past medical procedures included catheter placement, medical device removal, catheter removal and medical device implantation.The participant's concurrent conditions included anaemia, skin disorder, dermatitis atopic, visual impairment, epilepsy, device breakage, neuronal ceroid lipofuscinosis, hypertonia, dermatitis and pyrexia.No allergies were reported.Concomitant medications included paracetamol, diazepam, chlorhexidine gluconate, ibuprofen, diphenhydramine hydrochloride, lidocaine hydrochloride, betamethasone valerate, tacrolimus, triamcinolone acetonide, ascorbic acid/cyanocobalamin/ergocalciferol/folic acid/iron/nicotinamide/pyridoxine hydrochloride/retinol/riboflavin/thiamine hydrochloride/tocopherol, petrolatum, clobazam and levetiracetam.The paracetamol, chlorhexidine gluconate, ibuprofen, diphenhydramine hydrochloride and lidocaine hydrochloride was administered as premedication." "on (b)(4) 2017 the participant underwent an implantation of a catheter placement set (cath bactiseal clr w/ barium-log 118286 (model and catalogue number ns0338).The lot number for the catheter was h65382." "on (b)(4) 2017, the participant initiated treatment with brineura (300 milligram, qow, intracerebroventricular).The lot number for brineura was not reported." "on (b)(4) 2021, the participant underwent implantation of intracerebral ventriculostomy (icv) set (rickham 82-1625; catalogue number 821625).The lot number was 4706837." "on (b)(4) 2024 at 10:20, the participant experienced grade 3 device end of useful life (device end of service) during the brineura infusion and was hospitalized on the same date due to the event.The participant's port was accessed with no difficulty.The most recent dose of brineura was administered on (b)(4) 2024 at 14:45.After the infusion, the participant had a fever but this seemed to be what was usually seen.The participant was afebrile prior to the infusion.On the same date, around 19:00 the participant's father contacted the investigator and found the participant's pillow to be wet.Both of the parents relayed to the investigator that they did not note any leakage after the de-access in the infusion center at around 14:00.The participant was asleep but was easily arousable.The participant smiled when they heard the investigator's voice.The participant had increased tone in both hamstring muscles, but it was also reported as baseline.The investigator agreed with another physician's plan to remove the right frontal ventricular access device (vad).At the time of this report, the investigator was waiting on antibiotic recommendations and would most likely re-implant a new vad on the contralateral area.The investigator discussed these plans with the parents, and they were in agreement.On (b)(4) 2024 the participant's catheter and icv device were removed.At the time of this report, the participant's cerebrospinal fluid (csf) culture was pending.The operator of both devices was the investigator and the location of the event occurred at the hospital.It was not reported if the devices could be returned.No laboratory or diagnostic tests were reported.No treatment for the event was reported.The action taken with brineura was not applicable." "the outcome of the event was reported as recovering/resolving." "the investigator assessed the event as medically significant." "the investigator assessed the event of device end of service as not related to treatment with brineura; related to the icv device.Other etiological factors included skin and device breakdown." case comment: "icv device was prophylactically replaced due to end of life cycle of device.It is usually due to material degradation of device because of long periods of use.The causality of event is assessed as not related to brineura." additional information received on 21-mar-2024: "on (b)(6) 2024 the participant underwent implantation of a rickham icv set model 82-1625 (lot number 6909320) a left chest reservoir placement and left chest catheter placement.None of the replaced devices were available for return." "the outcome of the event was recovered/resolved on 20-mar-2024." "on (b)(6) 2024, the participant was due to have her brineura infusion; however, since the new ports were just placed, it would be approximately 9 days before the brineura infusion would be administered due to healing time." additional information received on 02-apr-2024."on (b)(6) 2024 at 22:38 the onset of the event occurred.The participant was admitted to the hospital with csf leak.On (b)(6) 2024 the rickham was removed.As a precautionary measure the participant received 10 days of unspecified intravenous (iv) antibiotics per recommendations of the infectious disease.There was no organism found on the port tap prior to initiation of antibiotics.On (b)(6) 2024 the participant had a procedure for replacement of ventricular access device with a chest port." "the outcome of the event was recovered/resolved on 21-mar-2024 at 18:05.".
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The reservoir (id 821625) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Additional information received: "the previously reported event of device end of useful life (device end of service) was updated by the investigator to device leakage (device leakage)." "the investigator assessed the event of device leakage as not related to treatment with brineura.The investigator assessed the event of device leakage as related to the icv device.Other etiological factors included skin and device breakdown." case comment: "additional information received.The event reported as device end of useful life was updated by the investigator to device leakage.Device leakage is a known complication of icv device use.The causality of device leakage is assessed as not related to brineura.".
Additional Manufacturer Narrative
Additional information: "treatment for the event included ceftriaxone sodium and dextrose.".
Additional Manufacturer Narrative
Additional information: "the action taken with brinerua due to the event was updated from no change to withdrawn on an unspecified date.".
Event or Problem Description
N/a.

• Brand Name: VENT RES TR SAL-RIC ST BA
• Common Device Name: RESERVOIRS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19084709
• Report Number: 3013886523-2024-00099
• Device Sequence Number: 7628913
• Product Code: JXG
• UDI-Device Identifier: 10381780517795
• UDI-Public: (01)10381780517795(17)260430(10)4706837
• Combination Product (Y/N): N
• PMA/510(K) Number: K102961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/17/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 821625
• Device Lot Number: 4706837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 04/15/2024; 06/26/2024; 09/25/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 04/26/2024; 07/19/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACETAMINOPHEN (PARACETAMOL).; ACETAMINOPHEN (PARACETAMOL).; BETAMETHASONE VALERATE.; CHLORHEXIDINE GLUCONATE.; CLOBAZAM (CLOBAZAM).; CLOBAZAM (CLOBAZAM).; DERMAPHOR (PETROLATUM).; DIAZEPAM (DIAZEPAM).; DIPHENHYDRAMINE.; IBUPROFEN (IBUPROFEN).; KEPPRA (LEVETIRACETAM).; KEPPRA (LEVETIRACETAM).; LIDOCAINE (LIDOCAINE HYDROCHLORIDE).; MULTIVITAMINS WITH IRON.; TACROLIMUS (TACROLIMUS).; TRIAMCINOLONE ACETONIDE.
• Patient Age: 9 YR
• Patient Sex: Female