MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD NEUROMONITOR BASIC KIT; ICP MICROSENSORS

Catalog Number	826631
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A physician reported that the tip of the microsensor (id 826631) was torn off when explanting a week after implantation.The torn part remains in the patient¿s body.Considering the advanced age of the patient (not provided), there seems to be no plan to explant the remaining device at this point.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The microsensor (id 826631) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint could be due to insufficient catheter and joint strength.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.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The microsensor (id 826631) was returned for evaluation.Device history record (dhr) - the product code 826631 with lot 7449285 sn (b)(6), conformed to the specifications when released to stock.Failure analysis - the catheter received with distal end missing approximately 3.5 cm from tip: crimped/torn.The tubing is not brittle, and catheter stretched 100% prior to breakage.The catheter mashed 7.5 cm from distal end and has black ink markings along body, crimped 3 cm from connector end and tape around connector.The internal wires crimped, stretched and broken (x-rays).No further testing possible.The complaint was confirmed.Root cause analysis - the possible root cause for the issue reported by the customer could be due to mishandling of the catheter.

• Brand Name: NEUROMONITOR BASIC KIT
• Common Device Name: ICP MICROSENSORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22017752
• Report Number: 3013886523-2025-00103
• Device Sequence Number: 8804871
• Product Code: GWM
• UDI-Device Identifier: 10381780520504
• UDI-Public: (01)10381780520504(17)291031(10)7449285
• Combination Product (Y/N): N
• PMA/510(K) Number: K914479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 826631
• Device Lot Number: 7449285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 09/10/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/25/2025; 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown