MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number SR-200-NPS

Device Problems Dent in Material (2526); Device Markings/Labelling Problem (2911)

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

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

The arterial sheath was returned for investigation.The sheath stopper and flow controller were not returned.Upon visual inspection, it was observed that pad printed numbers 1, 2, and 3 on the arterial sheath body were partially missing.The pad printed numbers 4 and 5 were intact but displayed uneven edges.There was indentation noted on the tip of the arterial sheath.Upon functional testing, the integrity of the pad printing on the complaint device remained consistent and passed the acceptance criteria of the testing protocol.As the filter was not returned, the black material in the filter could not be confirmed.The root cause of the reported issue could not be conclusively determined upon device investigation.There is no evidence to suggest that this device failed to meet specifications before distribution.Silk road medical will continue to monitor for occurrences of similar events.All reasonably available information has been provided by the company at the time of submission of this report.The fields that are blank are not an omission and indicate that the information is either not applicable or currently unavailable.A follow-up mdr will be submitted if additional information is received.

Event Description

It was reported that after completion of a left transcarotid artery revascularization (tcar) procedure, bits of black material were identified inside the filter of the neuroprotection system (nps).Additionally, it was noted that portions of the markings on the arterial sheath were missing.The physician believed the sheath got pushed into the calcium, causing the markings to rub off, as it was a highly calcified lesion.Additional information revealed that flow reversal had been established when the arterial sheath tip contacted the calcium in the vessel.The procedure was completed successfully with no reported health consequences or impact to the patient.

• Brand Name: ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: shelrin devi ; 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 18700224
• MDR Text Key: 335296106
• Report Number: 3014526664-2024-00039
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/13/2024

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: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 305344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female