MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR ICP SENSOR CATHETER KIT; ICP MICROSENSORS

Catalog Number 826633

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

Microsensor was returned for evaluation: udi - (b)(4).Dhr - the unit met all manufacturing quality testing/inspection specifications at the time of distribution.Failure analysis - the resistor was not making contact in the connector due to a faulty solder joint.There was no visible damage to the millar sensor, catheter material or the connector.The unit was tested by soldering the same value resister in and all tests passed after soldering the resistor in.Root cause - the root cause was attributed to this solder joint due to a manufacturing error by functional testing.No further investigation or corrective action is anticipated.

Event Description

A facility reported the microsensor could not be detected by the icp monitor during a procedure.The physician changed to another icp monitor and the issue persists, then "the physician gave up sing the microsensor".The event happened before use on the patient without surgical delay or patient consequences.

• Brand Name: ICP SENSOR CATHETER KIT
• Type of Device: ICP MICROSENSORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 325 paramount drive; raynham, MA 02767 ; 6099362319
• MDR Report Key: 10280906
• MDR Text Key: 203542281
• Report Number: 1226348-2020-00295
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2019

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 Expiration Date: 01/31/2023
• Device Catalogue Number: 826633
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2018
• 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