MAUDE Adverse Event Report: SILK ROAD MEDICAL ENROUTE ENFLATE TRANSCAROTID RX BALLOON DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Catalog Number	SR-6025-BC
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product associated with this complaint was not returned to the manufacturer for analysis.The reported event does not indicate a manufacturing defect and the finished product lot was verified to meet quality requirements and was released for commercial use in accordance with srm procedures.Complaints will continue to be reviewed and monitored for trends.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.If additional information is received, a supplemental report will be filed.
Event or Problem Description
It was reported that during a left transcarotid artery revascularization (tcar) procedure, during pre-dilatation of the enroute enflate transcarotid rx balloon, the balloon moved distal to the lesion.Imaging revealed a flow artifact.It was determined that the flow artifact was a dissection, due to the movement of the balloon.The physician placed an unplanned additional stent, and the procedure was completed successfully.

• Brand Name: ENROUTE ENFLATE TRANSCAROTID RX BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): SILK ROAD MEDICAL; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL; 1213 innsbruck dr.; sunnyvale CA 94089
• Manufacturer Contact: vincent lopez mireles ; 1213 innsbruck dr.; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 20450895
• Report Number: 3014526664-2024-00197
• Device Sequence Number: 17943044
• Product Code: LIT
• UDI-Device Identifier: 00811311020966
• UDI-Public: (01)00811311020966(17)250921(10)362621
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K221414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2025
• Device Catalogue Number: SR-6025-BC
• Device Lot Number: 362621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male