MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN BACTISEAL EVD CATHETER; BACTISEAL EVD CATHETERS

Catalog Number	821745
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
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
A facility reported an evd bactiseal catheter (id 821745) was inserted on (b)(6).2024.The patient had a positive csf culture for staphylococcus epidermidis after the evd was inserted.A routine culture was taken from the sample port near the collection chamber, no signs of csf infection were present.In october 5, a gram stain preliminary showed: many polymorphonuclear cells | no organisms seen primary culture: no growth after 72 hours / broth culture only: staphylococcus epidermidis.In october 8 a gram stain preliminary showed: polymorphonuclear cells present | rare squamous epithelial cells | rare gram-positive cocci.Culture - csf preliminary - scant growth of staphylococcus epidermidis.Therefore, the evd system was changed, not the catheter.A leukoplast, also known as coverplast fabric dressing, was used on the insertion site.
Additional Manufacturer Narrative
Additional information received.Csf cultures: sept 15 - neg, (b)(6) - neg, (b)(6)- neg, (b)(6) - neg - (b)(6): gram stain preliminary - many polymorphonuclear cells | no organisms seen - primary culture: no growth after 72 hours / broth culture only: staphylococcus epidermidis - (b)(6): gram stain preliminary - polymorphonuclear cells present | rare squamous epithelial cells | rare gram positive cocci - culture - csf preliminary - scant growth of staphylococcus epidermidis - evd system (not catheter) changed - (b)(6): gram stain preliminary - polymorphonuclear cells present | no organisms seen preliminary - culture - csf preliminary - scant growth of staphylococcus epidermidis.No cell count was done.- pt was not symptomatic of a csf infection at this time - is infection device related? if not, is it known what caused it? "yes" - did anything happen during the recent procedure that may have caused or attributed to infection? "lung infection and? (b)(6)" - was the patient placed on antibiotics? "yes" - what treatment and or medication was given for the infection? if medications were administered, please include medication names: "evd replaced and changed site.Antibiotics ¿ vancomycin, ceftriaxone, meropenum, ancef, flagyl, piptaz (not all at once)" - provide next course of action, if any: "the evd was removed and replaced." - what is the health history of the patient? "diagnosed with 4th ventricular tumor" - patient outcome or current status with regards to the infection.Csf infection cleared ¿ "vp shunt inserted.Eventually became symptomatic and diagnosed with another csf infection (staph epidermidis) ¿ vp shunt removed, evd inserted and on antibiotics" - please confirm if eds3 system is an integra product.If yes, please provide product information: "yes, this is an integra product.Sku (b)(4).Lot: not available".
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The evd bactiseal catheter (id 821745) was returned for evaluation.Device history record (dhr) - the product code 82-1745 with lot 7328489, conformed to the specifications when released to stock.All finished goods test results, including endotoxin satisfactorily met the requirements.Failure analysis - the catheter was visually inspected; no defect was noted.The catheter was irrigated, no occlusion noted.The catheter was leak tested no leak noted.Root cause analysis - the possible root cause for the issue reported by the customer, could be linked to the patient and hospital surroundings and as mentioned in the ifu: the quantities of rifampin and clindamycin hydrochloride used to impregnate the bactiseal evd catheter are only a fraction of a therapeutic dose of these two antibiotics and have no potential for any systemic therapeutic effect.
Event or Problem Description
N/a.

• Brand Name: CODMAN BACTISEAL EVD CATHETER
• Common Device Name: BACTISEAL EVD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20578472
• Report Number: 3013886523-2024-00331
• Device Sequence Number: 12786161
• Product Code: JXG
• UDI-Device Identifier: 10381780515593
• UDI-Public: (01)10381780515593(17)250131(10)7328489
• Combination Product (Y/N): N
• PMA/510(K) Number: K102589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: 821745
• Device Lot Number: 7328489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 12/19/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/26/2024; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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: EDS3 SYSTEM - SKU (B)(4).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown