MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC TRAPLINER CATHETER

Model Number	5567
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported, used a catheter once and then removed from the patient's body.When there was a second round to insert the catheter into the patient it fell apart at the entrance to the sheath.Additional information received stated catheter did not fall apart within the patient's body but it fell apart into the sheath.The doctor removed from the sheath used a new catheter and the secondary device was successful.
Additional Manufacturer Narrative
One-unit of trapliner was returned for evaluation.Blood particulates were noted on the catheter.Weld joint separation was observed.Lumen bulge/torque damages was observed on the rx lumen.Abrasion noted on the halfpipe.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 a procedure for cto.A trapliner was used in the case.The trapliner fell apart within the sheath.The damages are likely to have occurred during use in the procedure along with other devices and/or 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 fell apart during the second attempt into the sheath.A new trapliner was used to complete the case.Based on the information, the most likely root cause of the issue is operational context and/or unintended use error.

• Brand Name: TRAPLINER CATHETER
• 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: marling heaton ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 14621451
• Report Number: 2134812-2022-00032
• Device Sequence Number: 4588902
• Product Code: DQY
• UDI-Device Identifier: 10841156102135
• UDI-Public: (01)10841156102135(17)231129(10)714687
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2022

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: 11/29/2023
• Device Model Number: 5567
• Device Catalogue Number: 5567
• Device Lot Number: 714687
• 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: 05/08/2022
• Supplement Date Received by Manufacturer: 05/08/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• 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