MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR MICROSENSOR VENTRICULAR CATHETER KIT; ICP MICROSENSORS (ROHS)

Catalog Number 826653

Device Problem No Device Output (1435)

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

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 the ventricular microsensor could not be detected by the icp monitor (826635).Then the physician changed out the device which was able to be detected normally.The event happened during procedure, before implantation.No patient consequences and no surgical delay reported.

Event Description

N/a.

Manufacturer Narrative

The microsensor was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

The microsensor ventricular catheter kit was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - icp express passed with 514 reading.The device passed electronic, noise, and signal drift test; internal calibration and linearity/hysteresis tests were omitted due to the drainage tube.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.

Event Description

N/a.

• Brand Name: MICROSENSOR VENTRICULAR CATHETER KIT
• Type of Device: ICP MICROSENSORS (ROHS)
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11240804
• MDR Text Key: 232808408
• Report Number: 3014334038-2021-00014
• 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,Followup
• Report Date: 08/17/2021

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 826653
• Device Lot Number: J28W20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 02/26/2021; 06/04/2021
• Supplement Dates FDA Received: 03/17/2021; 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1