MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR ICP EXPRESS CABLE; ICP EXPRESS - CABLES

Model Number 826636

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/14/2023

Event Type  malfunction  

Event Description

A facility reported that at the start of the case, the surgeon was setting up a cerelink icp sensor but could not get the p-zero screen on the icp express monitor.The microsensor was attempted to be zeroed for approximately 30 minutes before integra¿s account manager was contacted.The account manager was supporting over the phone for approximately 15 minutes before the insertion procedure was abandoned and the spinal procedure commenced (the patient was scheduled for a spine surgery after sensor placement).At the end of the spinal procedure, the account manager was onsite to test the consoles and advise on successful insertion.Troubleshooting taken: a demo sensor was used by the integra account manager to test the two icp express monitors with their grey cables.One worked, one didn¿t.The account manager then swapped grey cables between monitors and found one cable was not working (cable 826636 lot 105512).Once the faulty cable was isolated and removed, medical staff were able to successfully complete zeroing steps.No issues after insertion.No variation in icp was noted, and icp sensor was removed after 24 hours.Reason for sensor placement; fall from height with spinal injuries and suspect bleeding on the brain.No issues were detected overnight and the icp was removed the following day.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The icp cable (id 826636) 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 cable was replaced with a new one.Therefore, the complaint condition could be confirmed.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could confirm the complaint.

Event Description

N/a.

• Brand Name: ICP EXPRESS CABLE
• Type of Device: ICP EXPRESS - CABLES
• 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: 17097712
• MDR Text Key: 317056743
• Report Number: 3014334038-2023-00089
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K945585
• 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: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 826636
• Device Catalogue Number: 826636
• Device Lot Number: 105512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1