MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC GUIDELINER CATHETER

Model Number 5569

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  Malfunction  

Manufacturer Narrative

There was no device returned for this event for evaluation, a conclusion for the failure could not be determined. The manufacturing records were reviewed and no nonconformances were related to this lot.

Event Description

5f guideliner was pulled and stent was loaded into the guideliner outside of the body an inserted into the guide catheter. Upon engaging the rca, the stent and guideliner were unable to advance into the mid rca, through multiple attempts to navigate the tortuosity, the stent was damaged and the stent struts were poking through the side of the guideliner, which was visualized upon removal of the guideliner. Stent and guideliner were removed safely from the body. No patient harm was caused. Additional information received: the stent struts did not poke through the guide catheter.

• Brand Name: GUIDELINER
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 7095456
• MDR Text Key: 95072485
• Report Number: 2134812-2017-00106
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K112082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/13/2017

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/07/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes

Device Operator

• Device EXPIRATION Date: 08/29/2019
• Device MODEL Number: 5569
• Device LOT Number: 612691
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 08/29/2017
• Is The Device Single Use?: Yes

Is this a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial