MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICROSENSOR VENTRICULAR CATHETER KIT; ICP MICROSENSORS (ROHS)

Model Number	82-6653
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	11/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported a microsensor (id 826653) was leaking csf during procedure after being implanted.The procedure was completed with a replacement product available and the event led to 20 minuets surgical delay.No patient consequences.
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
Microsensor catheter kit (id 826653) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Microsensor (id (b)(4)) has been returned for evaluation.Device history record (dhr)- based on the dhr review conducted, there is no indication that the production process may have contributed to this complaint.Failure analysis - a visual inspection showed no signs of damage.Water flow was tested through the catheter tubing.One flow test with the cap on and one flow test with the cap off.There were no leaks found.The device did meet the specifications.Root cause - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.

• Brand Name: MICROSENSOR VENTRICULAR CATHETER KIT
• Common Device Name: ICP MICROSENSORS (ROHS)
• 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: 16062429
• Report Number: 3014334038-2022-00287
• Device Sequence Number: 13964304
• Product Code: GWM
• UDI-Device Identifier: 20886704042492
• UDI-Public: 20886704042492
• Combination Product (Y/N): N
• PMA/510(K) Number: K991222
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2023

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: 02/28/2023
• Device Model Number: 82-6653
• Device Catalogue Number: 826653
• Device Lot Number: JC5669
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 04/17/2023; 07/28/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 04/27/2023; 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2020
• 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
• Patient Sex: Unknown