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 Failure of Implant (1924)

Event Date 05/14/2021

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 that three days after a codman ventricular microsensor was implanted to a patient the icp monitor could not detect the microsensor and did not show any readings.The physician retrieved the microsensor and stop monitoring.

Manufacturer Narrative

The codman ventricular microsensor 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 catheter was evaluated, and the following observations were noted: received catheter in a drainage tube.The sensor lead discolored.The sealant around sensor lifting.The icp express read ¿no transducer detected¿.There was no testing possible.Based on the evaluation, the complaint is confirmed.It is suspected that fluid entered at the lifting of the sealant around the sensor and caused corrosion.Per the complaint background, could not detect, no readings.The complaint was confirmed in the failure analysis.It is suspected that fluid entered at the lifting of the sealant around the sensor and caused corrosion.It is suspected that lifting of sealant was caused from inserting into drainage tube.As a result, no testing was possible.The root cause is ¿use related¿.Currently the complaint issue does not represent an adverse trend, however the issue will continue to be monitored and trended through the complaint evaluation process.

Event Description

N/a.

• 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
• MDR Report Key: 11956630
• MDR Text Key: 254859689
• Report Number: 3014334038-2021-00112
• 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
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

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: 02/28/2022
• Device Catalogue Number: 826653
• Device Lot Number: J7559N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1