MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC GUIDELINER V3

Model Number 5569

Device Problem Separation Problem (4043)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

One-unit of guideliner was returned to vsi/teleflex for evaluation.Blood particulates were found on the catheter.Multiple damages were noted on the catheter.The tip of the catheter was damaged and crimped.The half pipe and collar transition were severely damaged.Small layer of polymer material was noted to be stretched signifying catheter movement against resistance.The total length of the push rod was measured.Coil/torque damage was noted on the shaft.A kink was noted on the pushrod between 88-91 cm from the proximal hub.No other damage was observed along the length of the guideliner.The stent system was also returned for inspection.Kinks were noted on the shaft of the catheter of the stent.The distal stent was severely damaged.Contacted the physician to let him know that the 3.5mm stent is not compatible with the 5f guideliner and recommend using 3.0mm stents for the 5f guideliner.

Event Description

As reported: cto of the rca, 2nd attempt, physician had an 8f sheath down the vessel, tried to deliver a 6f guideliner but it wouldn't go, delivered a 5f guideliner mid-proximal, put down a stent and the physician stated, "it felt weird" so, he removed the whole system and the guide extension was hanging by a thread to the pushrod, and almost separated.No patient injury or medical intervention reported.

• Brand Name: GUIDELINER V3
• Type of Device: GUIDELINER V3
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 10446145
• MDR Text Key: 204254849
• Report Number: 2134812-2020-00048
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR