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

Catalog Number 826653

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 05/14/2023

Event Type  Injury  

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 Description

A facility reported a microsensor (id 826653) was implanted on (b)(6) 2023.One day after implantation, the icp monitor showed p-0, the microsensor could not show icp readings.The reported microsensor was removed and replaced on (b)(6) 2023.The patient is stable.The icp monitor used with the sensor was icp express, 220 volt (id 826635) and cable was icp express cable (id 826636).

Manufacturer Narrative

The microsensor (id 826653) was returned for evaluation.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the microsensor unit was inspected.The product was received in the drainage tube with suture tied 10.5cm from the sensor end.The catheter was tied in a knot 26cm from the connector end.The icp express read an appropriate icp value and device passed all functional testing.The supplier was unable to confirm the failure.Root cause - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.However, the potential root causes include user misuse or not informed of use.In addition, since the icp microsensor is used in conjunction with a cable and a monitor, it is possible that the failure was caused by one of the other products used with the microsensor.

• Brand Name: MICROSENSOR VENTRICULAR CATHETER KIT
• Type of Device: 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: 17038597
• MDR Text Key: 316390256
• Report Number: 3014334038-2023-00083
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K991222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 826653
• Device Lot Number: 6248689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/14/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ICP EXPRESS CABLE (ID 826636); ICP EXPRESS MONITOR (ID 826635)