MAUDE Adverse Event Report: INTEGRA - PRINCETON SUNDT EXTERNAL SHUNT 3MM X 4MM; N/A

Catalog Number	NL8505070
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that when placing the sundt external shunt (nl8505070), the surgeon observed an issue and had to change the shunt quickly.The carotid artery was clamped at the time of the occurrence.There was no allegation of patient injury.Additional information received indicating the following: do you have more details on the issue faced? shunt was flattened.- did the issue cause any increase of surgical time equal or superior to 30 minutes)? no increased time reported as devices changed at the beginning of the procedure.How did they finalize the surgery? use of another device available in stock? >> yes - "as per risk assessment performed by our clinician team, this case is considered as reportable.Potential for death or serious injury is not remote.Flattened carotid shunt may impede or reduce blood flow to the head and brain.Therefore, potential risk for serious injury is not remote.".
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.
Additional Manufacturer Narrative
Updated fields: the sundt external shunt (nl8505070) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - one (1) unit was received, and the reported lot number (6926448) and product catalog (nl8505070) were confirmed based on the product identification returned with the device.The shunt was visually inspected, and it was observed that the springs of the device were bent.Root case - based on the evaluation of the returned unit, the complaint is considered confirmed.Due to confirmed complaints related to kinked/bent carotid shunts, a corrective action was implemented to modify the thermoform cover to add an evacuation feature which will allow trays to expand and separate during eo sterilization process to avoid crushing/deformity of the trays.The reported fg lot 6926448 was manufactured and packaged prior to the implementation of the evacuation feature to the trays as part of the capa described above.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h11.This report is being sent to correct the aware date submitted in follow-up mdr #1.The aware date should have read 24apr2025 but was erroneously submitted as 08apr2025.
Event or Problem Description
N/a.

• Brand Name: SUNDT EXTERNAL SHUNT 3MM X 4MM
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ 08540
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ 08540
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21708976
• Report Number: 2648988-2025-00004
• Device Sequence Number: 9941973
• Product Code: DWF
• UDI-Device Identifier: 10381780026259
• UDI-Public: 10381780026259
• Combination Product (Y/N): N
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: NL8505070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 04/08/2025; 01/30/2026
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/20/2025; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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
• Patient Sex: Unknown