MAUDE Adverse Event Report: LAKE REGION MEDICAL ENROUTE,ST,MOD,S,HY,US 95-014

Model Number 901047-01

Device Problem Difficult to Advance (2920)

Patient Problem Vascular Dissection (3160)

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

Complaint investigation underway and will be attached to this report.

Event Description

It was reported that during a tcar procedure, the enroute wire had trouble advancing in the vessel.An angiogram revealed a dissection at the sheath tip.The physician pulled the sheath back and the wire was able to be advanced.The procedure was completed and no intervention was required.

• Brand Name: ENROUTE,ST,MOD,S,HY,US 95-014
• Type of Device: ENROUTE,ST,MOD,S,HY,US 95-014
• Manufacturer (Section D): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer (Section G): LAKE REGION MEDICAL; parkmore west business park; galway, H91 C K22; EI H91 CK22
• Manufacturer Contact: jaseem saqib ; parkmore west business park; galway, H91 C-K22 ; EI H91 CK22
• MDR Report Key: 18939526
• MDR Text Key: 338086639
• Report Number: 3006010712-2024-00018
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00811311020546
• UDI-Public: 00811311020546
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160643
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 901047-01
• Device Catalogue Number: SR-014-GW
• Device Lot Number: 8490212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2023
• 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