MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERELINK ICP PROBE 1L M BOLT; ICP MICRSOSENSORS - CERELINK

Catalog Number 826851

Device Problems High Readings (2459); Material Integrity Problem (2978)

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

Event Date 03/26/2023

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 cerelink sensor (id 826851) was implanted on (b)(6) 2023.The patient was showing icp of 3mmhg with proper waveform for approximately 2 hours, but then had reading of ~350mmhg and yellow light was displayed on directlink icp module.Yellow light would not begin to blink and turn green to confirm proper functioning of system.All cords were disconnected and reconnected.Proper calibration and reconnection process was performed, but issue persisted.Upon further inspection it was discovered that sensor had ¿thinner¿ parts to it that others.Another probe was brought it and it was found that implanted sensor was approximately 6cm longer than in-tact sensor.It is believed that sensor was stretched out and connection in sensor was severed.The sensor was explanted on (b)(6) 2023.

Manufacturer Narrative

The cerelink sensor (id 826851) was returned for evaluation.Device history record (dhr) - the product 826851 for lot 5842794 (sn (b)(6), and the lot met specifications when released.Failure analysis - the issue of the complaint has been confirmed: catheter stretched 34 and 51 cm from connector; and tape bunched up around catheter.Cerelink monitor read ¿not acceptable¿; icp express and no transducer detected.Internal wires broken, no testing was possible.The possible root cause of the issue reported by customer could be determined as a mishandling of the device the catheter.

Event Description

N/a.

• Brand Name: CERELINK ICP PROBE 1L M BOLT
• Type of Device: ICP MICRSOSENSORS - CERELINK
• 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: 16732122
• MDR Text Key: 313212465
• Report Number: 3013886523-2023-00107
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K173192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• 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: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 826851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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: DIRECTLINK EXTENSION CABLE.; DIRECTLINK ICP MODULE.; PHILLIPS BEDSIDE MONITOR CABLE.
• Patient Sex: Male