MAUDE Adverse Event Report: INTEGRA LIFESCIENCIES CORPORATION CAROTID STERIL LOOP SHUNT 3MM; STERILE SUNDT CAROTID LOOP SHUNT 3MM X 4MM

Model Number NL8505070

Device Problem Unclear Information (4052)

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

Event Date 03/28/2024

Event Type  malfunction  

Event Description

As reported, during an intervention, this carotid shunt (model number nl8505070) was detected incorrectly labeled.The device received was the model number nl8505066.For the surgeon, the issue lied in the fact that these two model numbers have different diameters.There was no allegation of patient injury.The device was not available for evaluation.(medwatch #(b)(4)).At the pharmacy, four additional units were found labeled incorrectly.Each package had three labels, two labels with model number nl8505066 and one label with model number nl8505070.There was no patient involved.The devices were available for evaluation.(medwatch #(b)(4)).As a summary, two medwatch reports will be submitted one for the device found during intervention and one for the four devices found in the pharmacy (medwatch # (b)(4) and medwatch # (b)(4)).

Manufacturer Narrative

There is no evidence of product malfunction or mislabeling from the manufacturer side.The device was re-labeled incorrectly at edwards warehouse for inventory purposes.Therefore, edwards lifesciences is reporting instead of the original manufacturer.Note that the code included in d2b is not applicable for this device since the carotid shunt is a preamendment device.The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: CAROTID STERIL LOOP SHUNT 3MM
• Type of Device: STERILE SUNDT CAROTID LOOP SHUNT 3MM X 4MM
• Manufacturer (Section D): INTEGRA LIFESCIENCIES CORPORATION; campus road, 1100; princeton NJ 08540
• Manufacturer (Section G): INTEGRA LIFESCIENCIES CORPORATION; campus road, 1100; princeton NJ 08540
• Manufacturer Contact: samantha eveleigh ; irvine, CA 92614 ; 9492503939
• MDR Report Key: 19178599
• MDR Text Key: 341790707
• Report Number: 2015691-2024-03105
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2024

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 Model Number: NL8505070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1