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

Model Number	5568A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been opened to review history record and risk documentation.A follow up report will be submitted after investigation.
Event or Problem Description
It was reported that: customer stated that the unit was noticed to be defective before it was to be loaded into the hemostasis valve.Additional information: during a coronary intervention, the device did not past the hemostasis valve and never entered the patient.The device broke in 2 pieces during a coronary intervention.No medical intervention was required.
Additional Manufacturer Narrative
One-unit of trapliner was returned for evaluation.Blood particulates were noted on the catheter.Weld joint separation was observed.The weld joint break was noted at 133.5 cm from the distal end of the hub.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 coronary intervention procedure.A trapliner was used in the case.The trapliner detached before it was loaded into the hemostasis valve.One unit of trapliner was returned for evaluation.Weld joint separation was observed.The damages are likely to have occurred during use in the procedure along with other devices when operated against resistance.Per ifu states the following warning and precaution: 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 from the account.A response was received.The trapliner did not make it past the hemostasis valve.No medical intervention was needed.Based on the information, the most likely root cause occurred during preparation for use of the catheter and is classified as operational context and/or unintended use error.

• Brand Name: TRAPLINER 8F
• Common Device Name: 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: elaine cully ; 6464 sycamore court north; minneapolis, MN 55369 ; 7366564300
• MDR Report Key: 15603716
• Report Number: 2134812-2022-00055
• Device Sequence Number: 19412014
• Product Code: DQY
• UDI-Device Identifier: 10841156102142
• UDI-Public: (01)10841156102142(17)240831(10)719814
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 5568A
• Device Catalogue Number: 5568
• Device Lot Number: 719814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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
• Patient Sex: Unknown