MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC TRAPLINER 8F; CATHETER, PERCUTANEOUS

Model Number	5568
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).An investigation has been opened to review historical data and risk documentation.A follow up report will be submitted after invesigation.
Event or Problem Description
It was reported that the cardiologist was performing a complex cto to the lad.The trapliner was used.There was retrograde and antegrade access via right radial.Micro-catheters and guidewires were used in the vessel.An intravascular ultrasound (ivus) attempt was unsuccessful - unable to progress through catheter is area of subclavian.The guidewires were stuck in the catheter.When the trapliner was removed, a split was identified on the catheter.Additional information on 23feb2023: the account reported that there was multiple 0.014" guidewires in the trapliner catheter.A 135cm microcatheter was also used during the procedure.Guidewire access was eventually lost during the procedure.The trapliner was removed in its entirety, and no fragments were left in the vessel.It was reported that the perforation occurred in the distal lad and was treated with 2x2mm coils.There was no report of significant blood loss, and the patient did not require any blood transfusions.It was reported that the patient received additional hospitalization/medical care due to this event.The cto was aborted due to the perforation.The patient's current condition is reported as fine.
Event or Problem Description
It was reported that the cardiologist was performing a complex cto to the lad.The trapliner was used.There was retrograde and antegrade access via right radial.Micro-catheters and guidewires were used in the vessel.An intravascular ultrasound (ivus) attempt was unsuccessful - unable to progress through catheter is area of subclavian.The guidewires were stuck in the catheter.When the trapliner was removed, a split was identified on the catheter.Additional information on 23feb2023: the account reported that there was multiple 0.014" guidewires in the trapliner catheter.A 135cm microcatheter was also used during the procedure.Guidewire access was eventually lost during the procedure.The trapliner was removed in its entirety, and no fragments were left in the vessel.It was reported that the perforation occurred in the distal lad and was treated with 2x2mm coils.There was no report of significant blood loss, and the patient did not require any blood transfusions.It was reported that the patient received additional hospitalization/medical care due to this event.The cto was aborted due to the perforation.The patient's current condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).One-unit of trapliner was returned for evaluation.Blood particulates were noted on the unit.The half-pipe of the trapliner was observed to be damaged and split partially.No other damages noted.The top-level assembly traveler was reviewed.There are no dda's, nce's or any other nonconformances related to this lot therefore supporting the device met material, assembly , and performance specifications.Case details were reviewed.A patient underwent a procedure for a cto to lad.A trapliner was used in the case.Customer stated "retrograde and antegrade access were achieved via right radial artery.Microcatheters in situ 0.014" specialty guidewires in vessel.Intravascular ultrasound imaging catheter attempt was unsuccessful - unable to progress through catheter is area of subclavian.Guidewires were stuck on the catheter.Trapliner was removed and observed to be split." damages are likely to have occurred during interaction and use along with other devices in the procedure.Per ifu the following warning and precaution were noted: never advance, withdraw, or rotate an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the catheter against resistance may result in separation of the catheter or guidewire tip, other device damage, or vessel injury.Exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage or kinking.Do not apply torque to the catheter during delivery, as catheter damage may result.Additional information was requested.A response was received.Perforation was noted on the distal lad.Micro coils were used.No blood transfusion done.Procedure was aborted.Patient condition is fine.Per intake information, trapliner, microcatheters along with the specialty 0.014" guidewires were in situ in the vessel.Intravascular ultrasound imaging catheter could not be advanced successfully through the catheter in the subclavian.It is likely due to concomitant device interaction of the trapliner, with other devices could have led to the half pipe partially splitting subsequently leading to advancement issue.It is unknown if the half-pipe was damaged during the advancement of the intravascular ultrasound imaging catheter in which there could have been a guidewire wrap along the proximal end shearing the lumen partially.Or if it happened during the placement of microcatheters in situ prior to the use of the intravascular ultrasound imaging catheter.No confirmation or angiograms pertaining to the events were provided by the account.Based on the damages noted on the returned product, it is indicative of device interaction.It is unlikely that the vessel perforation was due to the trapliner as the location of where the issue occurred was distal lad.It is likely the guidewire though no confirmation or details were provided.Per ifu, vessel perforation is identified as a potential adverse effect that maybe associated with the use of trapliner.No information was shared on how perforation occurred.A manufacturing record review was completed and no related nonconformances were found.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.

• Brand Name: TRAPLINER 8F
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: angela meister ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16440043
• Report Number: 2134812-2023-00007
• Device Sequence Number: 7249985
• Product Code: DQY
• UDI-Device Identifier: 10841156102142
• UDI-Public: 10841156102142
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: 5568
• Device Catalogue Number: 5568
• Device Lot Number: 716515
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 73 KG