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

Catalog Number 626631

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2021

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 the transducer of a microsensor did not recognize the icp express when connected.The medical staff was able to get it recognized, however, when zeroing the sensor, a stable connection between the micro-sensor and the icp unit could not be achieved.The event happened before ventricle placement and the procedure was completed with another product available.No patient injury reported and the event led to 15 minutes surgical delay.

Manufacturer Narrative

The microsensor was returned for evaluation.Device history record (dhr) - the product code 626631 with lot 5101867 conformed to the specifications when released to stock.Failure analysis - the issue of the complaint was not confirmed.No visible damage to the millar sensor, catheter material, or connector.Icp express passed with reading 484.The device passed electronic, noise, linearity/hysteresis, and signal drift tests.The root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause for this issue reported by the customer could be due to excessive pressure applied to product.

Event Description

N/a.

• Brand Name: MICROSENSOR BASIC KIT R
• Type of Device: ICP MICROSENSORS (ROHS)
• 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 ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12375545
• MDR Text Key: 268459931
• Report Number: 3013886523-2021-00375
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K153347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

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: 10/31/2022
• Device Catalogue Number: 626631
• Device Lot Number: 5101867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 11/18/2021
• Supplement Dates FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2020
• 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