MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. MICROSENSOR VENTRICULAR CATHETER KIT; DEVICE, INTRACRANIAL PRESSURE MONITORING

Model Number	82-6653
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been reported that the device will be returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the affiliate, during pre-use testing prior to use on the patient, a microsensor registered no data after being connected to an icp monitor.Monitoring was discontinued.There were no reports of delays or patient harm.
Additional Manufacturer Narrative
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The component was returned for evaluation.It was found that the sensor diaphragm was broken (a depressed square was observed).Due to the condition of the device as it was returned, no functional testing was possible.A review of manufacturing records for both the component and finished good found no discrepancies.The supplier was able to confirm that there was an issue with the device; however, due to the condition of the device, the specific failure was not able to be confirmed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: MICROSENSOR VENTRICULAR CATHETER KIT
• Common Device Name: DEVICE, INTRACRANIAL PRESSURE MONITORING
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham 02767
• MDR Report Key: 7719856
• Report Number: 1226348-2018-10514
• Device Sequence Number: 16410309
• Product Code: GWM
• UDI-Device Identifier: 20886704042492
• UDI-Public: (01)20886704042492(10)H29883
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K991222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2018

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
• Operator of Device: Health Professional
• Device Model Number: 82-6653
• Device Catalogue Number: 82-6653
• Device Lot Number: H29883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 07/01/2018
• Supplement Date Received by Manufacturer: 07/26/2018; 09/04/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/16/2018; 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1