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

Model Number 5571

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Vascular Dissection (3160)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing record was reviewed, there were no non-conformances related to this lot, therefore, supporting the met material, assembly, and performance specifications.A follow-up report will be issued after the investigation is complete.

Event Description

As reported: guideliner in left cx artery dissected vessel.Per tech: "the patient is fine.It was a very tortuous vessel lots of calcium with no support from the guide.The stent came off the balloon.The guideliner was seated pretty far in the vessel.Patient was sent to surgery.

Manufacturer Narrative

Case details were reviewed.A patient underwent a pci procedure.A guideliner 6f was used in the case.It states that the guideliner in the left cx artery dissected the vessel.No product was returned to vsi/teleflex for evaluation.Additional information was requested from the account.A response was received.The vessel was very tortuous and severely calcified.The circum flex vessel came of the left main at a sharp angle.The guideliner was seated far in the vessel.The distal vessel size is unknown.Per ifu it states the following warning and precaution - never advance the guideliner catheter into a vessel with an effective diameter less than 2.5mm.Vessel injury and/or occlusion may result.If pressure in a vessel dampens after inserting the guideliner catheter, withdraw the catheter until the pressure returns to normal - due to the size and non-tapered tip of the guideliner catheter, extreme care must be taken to avoid vessel occlusion and damage to the wall of the vessels through which this catheter passes.- never advance the guideliner catheter more than 10cm beyond the tip of the guide catheter as the guideliner catheter may become lodged in the guide catheter making it difficult to remove the stent came off the balloon during procedure.It is unknown if the there was any concomitant device interaction of the stent with the gl causing it to dislodge or if the undeployed stent was withdrawn back without simultaneously pulling back the gl subsequently leading to dislodgement.Operating (advancement or withdrawal) catheter against resistance can also lead to vessel injury (i.E dissection).The following precaution from ifu states - do not withdraw an undeployed stent back into the guideliner catheter when the catheter is in the body, as it may result in dislodging the stent.Instead, simultaneously pull both the guideliner catheter and undeployed stent back into the guide and remove together - never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter or guidewire against resistance may result in separation of the catheter or guidewire tip, damage to the catheter, or vessel damage per event details, dissection was noted in the part of the vessel that the gl was sitting when it was pulled back into the guide.The guide catheter was used per ifu: -vessel dissection and stent dislodgement are identified as a potential adverse effect that maybe associated with use of guideliner.It is unknown where exactly in the cx vessel was the dissection noted (distal or proximal vessel).It is unknown if the stent catheter system post dislodging could have caused dissection during withdrawal as anatomical factors were difficult due to sharp angle.No angiograms or images were shared pertaining to the issue and anatomy of the vessel condition the procedure was aborted, and patient was sent to surgery.The patient condition is fine.Based on the information and no product evaluation, the most likely root cause of the issue is undeterminable.

• Brand Name: GUIDELINER V3
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 12060359
• MDR Text Key: 264698566
• Report Number: 2134812-2021-00048
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 30841156100609
• UDI-Public: (01)30841156100609
• Combination Product (y/n): N
• PMA/PMN Number: K172090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2022
• Device Model Number: 5571
• Device Lot Number: 703824
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention