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

Catalog Number 826633

Device Problem Connection Problem (2900)

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

Event Date 06/18/2021

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 on (b)(6) 2021 a codman icp monitor (826635) was not able to detect the icp microsensor (826633) prior to implantation.The doctor changed to a new microsensor of the same type.The icp monitor then worked normally.

Event Description

N/a.

Manufacturer Narrative

The 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 - no visible damage to the millar sensor, catheter material, or connector.The icp express reading passed with 571.The device passed electronic, noise, and signal drift tests.The supplier was unable to confirm the complaint.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A dhr review, trending, and risk assessment were performed as part of the evaluation.Product was received for analysis and the investigation could not confirm the complaint.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.The risk remains acceptable per the risk analysis.

• Brand Name: ICP SENSOR CATHETER KIT
• Type of Device: ICP MICROSENSORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 12147593
• MDR Text Key: 264283480
• Report Number: 3014334038-2021-00129
• 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
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 826633
• Device Lot Number: J8268A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1