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

Model Number	626631US
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
2 of 2 reports.Other mfg report number: 3013886523-2023-00125.A facility reported that when surgeon placed the first sensor (b)(6) on (b)(6) 2023, after implantation site closure, it was noticed there was no waveform present.Surgeon decided to replace the first sensor and a second sensor was placed (b)(6)on (b)(6) 2023.The second sensor would not detect pressure and would fluctuate to negative values (noticed before implantation site closure).Surgeon then removed the second sensor and replaced with a third sensor.The third sensor worked fine with no reported issues.
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.
Additional Manufacturer Narrative
The microsensor basic kit (id 626631us) was returned for evaluation.Device history record (dhr)- the product 626631us for lot 6500217 (sn (b)(6)), and the lot met specifications when released.Failure analysis - no visible damage to the millar sensor, catheter material, or connector.Icp express read 578.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.
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: 16827884
• Report Number: 3013886523-2023-00126
• Device Sequence Number: 1842267
• Product Code: GWM
• UDI-Device Identifier: 10381780514473
• UDI-Public: (01)10381780514473(17)240531(10)6500217
• Combination Product (Y/N): N
• PMA/510(K) Number: K153347
• 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
• Report Date (Section B): 07/19/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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 Sex: Unknown