MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CODMAN MICROSENSOR BASIC KIT; ICP MICROSENSORS (3T)

Model Number	626631US
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Failure of Implant (1924)
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 a microsensor ((b)(4)) was placed on (b)(6), 2022 at 10:50 am and was connected to a direct link.The icp was 25 mmhg after implantation.No post-op imaging was obtained.The direct link was connected to a phillips monitor when the patient was already in the icu.On (b)(6) 2022 at 2300hh the icp was noted to be negative 4 mmhg to negative 11 mmhg, then negative 16 mmhg, then negative 28 mmhg.Per report, the monitor was disconnected and reconnected.During that time the patient was playing with toys in the hospital bed, and denied a headache.Within 45 minutes the icp was 1mmhg then 15 mmhg.On (b)(6), 2022 in the morning the patient was sleeping on their left side and the icp was 25mmhg, the patient was repositioned and the icp appropriately was then <20 mmhg (not a negative reading).On (b)(6) 2022 at 18:00hh, the icp was negative 2 mmhg.Then from 2100hh until 0100hh on (b)(6), 2022, the icp went to negative 26 mmhg while the patient was asleep with head of bed elevated.On (b)(6), 2022 at 0200hh the icp was 8 mmhg.The microsensor was removed and replaced on april 22, 2022.The icp was 22mmhg when initially placed then settled to a range of 9-13mm hg.The patient is an (b)(6) female with a history of pediatric bicoronal synostosis s/p fronto-orbital advancement and cranial vault reconstruction in 2014.Papilledema was noted in 2018 and the patient had an icp monitor placed with icps reportedly 20-30mmhg and was subsequently taken for a total cranial vault reconstruction.In (b)(6) of 2022 patient was noted to have papilledema and was scheduled for elective placement of an icp monitor on (b)(6) 2022.
Additional Manufacturer Narrative
Updated fields:  d4, d9, g3, g6, h2, h3, h6, h10.The microsensor (id (b)(6)) was returned for evaluation.Failure analysis - the issue of the complaint was not confirmed.Catheter mashed 26.5cm from tip.Unable to verify serial number due to label missing from connector.Cerelink monitor was acceptable, icp express reading 419.The device passed electronic, noise, linearity/hysteresis, and signal drift tests.The root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause of the defect reported by the customer could be due to incorrect set-up of device.Furthermore, mash of catheter observed during product investigation could be probably due to a mishandling, as noted in the ifu of the product the device 626631us must be used with care to avoid any damaged.
Event or Problem Description
N/a.

• Brand Name: CODMAN MICROSENSOR BASIC KIT
• Common Device Name: ICP MICROSENSORS (3T)
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14340596
• Report Number: 3013886523-2022-00186
• Device Sequence Number: 12083439
• Product Code: GWM
• UDI-Device Identifier: 10381780514473
• UDI-Public: 10381780514473
• Combination Product (Y/N): N
• PMA/510(K) Number: K153347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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 Model Number: 626631US
• Device Catalogue Number: 626631US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 8 YR
• Patient Sex: Female