MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD UNKNOWN CERELINK; ICP MICRSOSENSORS - CERELINK

Catalog Number XXX - CERELINK

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/23/2021

Event Type  malfunction  

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

2 of 3 reports: same facility, same failure, same product, different patients.Other mfg report numbers: 3013886523-2021-00176, 3013886523-2021-00232.A facility reported a cerelink probe was implanted on (b)(6), 2021 and explanted on (b)(6), 2021.It was documented as intact when explanted; however, the tip was noticed on a head ct scan on (b)(6), 2021.No additional information was provided after several attempts.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.Complaint sample was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer 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.Based on a meeting that took place between integra and the hospital, it was concluded that the root cause of the issue reported by customer was due to an user error.Junior registrars will be trained in placing the icp bolts, and training will be provided to physicians and nurses to improve understanding of probe implantation and removal.

Event Description

N/a.

• Brand Name: UNKNOWN CERELINK
• Type of Device: ICP MICRSOSENSORS - CERELINK
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• MDR Report Key: 11891578
• MDR Text Key: 256736819
• Report Number: 3013886523-2021-00231
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX - CERELINK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1