MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC GUIDELINER V3; CATHETER

Model Number 5571

Device Problem Separation Problem (4043)

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

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

One guideliner catheter, was returned for evaluation.The manufacturing record review was completed and no related nonconformance's were found.There are no related nonconformance associated with this lot therefore supporting the device met material, assembly and performance specifications.The shaft successfully passed through a ring gage confirming it was within specification.The guideliner was visually examined and found to be severely damaged.The half-pipe channel / collar transition was damaged and twisted.The half-pipe channel was twisted, and the pushrod was beginning to pull away from the device.This damage is consistent with extending the guideliner more than 10cm outside the guide catheter (guide sheath).It is likely that upon withdrawing the guideliner back into the guide catheter (guide sheath), the collar of the guideliner became stuck on the distal section of the guide catheter (guide sheath).Further removal of the guideliner would then cause the pushrod to pull away from the device.

Event Description

Pci was performed for right sfa to pop artery with high calcification.After treating sfa with a cto recanalization catheter, a guideliner was inserted from right access through 6fr guide sheath.A balloon was dilated, and advanced gradually, and guideliner was followed the balloon.Guideliner was going to be delivered to pop artery, but it got stuck around sfa.Guideliner was removed from the body, and further operation was continued without guideliner.After the operation, guideliner was visually checked.It was confirmed that pushrod is about to come off from collar part (not completely detached).No patient injury or impact reported.

• Brand Name: GUIDELINER V3
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 8722284
• MDR Text Key: 149098667
• Report Number: 2134812-2019-00047
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: +M206557103
• UDI-Public: +M206557103
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2019
• Device Model Number: 5571
• Device Lot Number: 617894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2019
• 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