MAUDE Adverse Event Report: RAYNHAM ICP SENSOR CATHETER KIT; ICP MICROSENSORS

Catalog Number 826633

Device Problem No Device Output (1435)

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

Event Date 11/01/2021

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

A facility reported that after implantation of the icp sensor catheter kit (id 826633), the microsensor could not be detected by the icp monitor (id 826635).It was changed with another icp which still could not detect the microsensor.The microsensor was replaced, and the procedure was completed.There was a delay of 20 minutes.The issue was detected before implantation site closure.

Manufacturer Narrative

The icp sensor (826633) 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 icp express read ¿no transducer detected¿.The catheter stretched 29 to 36 cm from tip.Internal wires are broken inside catheter at stretched area (x-ray).No testing was possible.The supplier was able to confirm the complaint.The root cause is ¿mishandling of the catheter¿.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.

• Brand Name: ICP SENSOR CATHETER KIT
• Type of Device: ICP MICROSENSORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12830440
• MDR Text Key: 282910306
• Report Number: 3014334038-2021-00234
• 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: 01/25/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 826633
• Device Lot Number: JD0623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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