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

Catalog Number 62-6631

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The provided product code is not sold in the us.The gtin and 510k provided are for the us device most similar to the suspect product.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 Description

As reported by the ous affiliate, a day after a microsensor was implanted, it started to fluctuate and show positive, then negative readings.It was revised with another and the readings were accurate.An icp cord is also involved.

Manufacturer Narrative

The sensor was returned for evaluation.The internal wires were broken inside the catheter, which was stretched and kinked along its body.Due to the condition of the sensor as it was returned, no functional testing was possible.A review of quality records for the component found the sensor met all manufacturing and quality testing/inspection specifications.The icp express cable used in this system was also returned.While no specific failure was indicated, the device was tested and found to be working properly.Based on the information provided, the reported issue is not able to be confirmed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

Manufacturer Narrative

The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

• Brand Name: ROHS MICROSENSOR BASIC KIT
• Type of Device: DEVICE, INTRACRANIAL PRESSURE MONITORING
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7371159
• MDR Text Key: 103483322
• Report Number: 1226348-2018-10232
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K914479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 62-6631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Date Manufacturer Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 826636 - ICP EXPRESS CABLE; 826636 - ICP EXPRESS CABLE
• Patient Outcome(s): Required Intervention