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

Model Number	626631US
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/13/2022
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 (id (b)(4) broke in two parts while removing it from the patient.The provider was able to remove a 3cm piece as well as the distal portion of the microsensor but the sensor-tip along with 2 to 3cm of sensor remained in the patient¿s parenchyma.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The microsensor (id 626631us) was returned for evaluation.Device history record (dhr) - the product 626631us for lot 6234325 (sn (b)(6)), and the lot met specifications when released.Failure analysis - the issue of the complaint has been confirmed.Received catheter with no case or sensor.Multiple kinks and catheter stretched 101cm from connector.No testing was possible, catheter has to be intact in order to test.The root cause of the damage device could be determined as a mishandling of the catheter with excessive force.

• 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: 15710909
• Report Number: 3013886523-2022-00492
• Device Sequence Number: 5132108
• 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 Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 626631US
• Device Catalogue Number: 626631US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2022
• 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