MAUDE Adverse Event Report: RAYNHAM MICROSENSOR VENTRICULAR CATHETER KIT; ICP MICROSENSORS (ROHS)

Catalog Number 826653

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2019

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that the microsensor could not be detected by the icp and then the physician changed with another icp which still could not detect the microsensor.Therefore the problem was with the microsensor.The physician stopped monitoring.The event occurred pre operatively; there were no delays and no adverse consequences.The device will be returned.

Event Description

N/a.

Manufacturer Narrative

Udi (b)(4).The catheter was evaluated and the following observations were noted.Received catheter in drainage tube, the internal wires were broken(x-ray).The adhesive was dirty or the sensor area.No testing was possible.Device history records (dhrs) were reviewed and no anomalies were found.The complaint failure has been confirmed.The root cause was due to mishandling of the catheter.No further investigation or corrective action is anticipated.

• Brand Name: MICROSENSOR VENTRICULAR CATHETER KIT
• Type of Device: ICP MICROSENSORS (ROHS)
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8671262
• MDR Text Key: 147080484
• Report Number: 1226348-2019-00186
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 826653
• Device Lot Number: HU9804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1