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

Model Number	5566
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
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: as reported: cto of rca.Trapliner used in antegrade 6fr.Guide catheter.High resistance was felt to move the catheter and other microcatheters.Found 2 cycles of wire wrap.Correction of wrap did not resolve the problem with the high resistance.When trapliner was removed, there was separation of the half pipe from the ribbon wire push rod.It is unknown if this was caused by the high tension within the system.Trapliner was never more than 5cm outside of the guide catheter throughout the procedure.
Additional Manufacturer Narrative
A returned product evaluation was completed.The pushrod was delaminated/separated from the halfpipe.The lumen of the halfpipe were crimped and damaged.Blood particulates were found on the catheter.Partial delamination of the pushrod from the halfpipe was observed.The halfpipe lumen was crimped.Small parts of pebax were noted on the pushrod.No other damages noted on the rx lumen.Length, collar to tip, o.D, i.D, were measured and within specification.Lot was reviewed.There are no non-conformances related to this lot therefore supporting the device met material, assembly and performance specifications.Damages found on the unit is likely to have occurred during use with other products during procedure.Wire wrap was noted.Vessel was calcified with no tortuosity.Resistance was noted with the catheter.Two coronary cto re-entry systems were used and both experienced resistance issues with the trapliner.The patient condition is fine."this device was sent for testing, which concluded that an abundance of the biological deposits from the surgical use of this device was present" and "scar was issued to supplier to implement update to cleaning process." the investigation concluded that there was no residue linked to the cleaning and passivation process found on this lot, but also states that "any presence of residue could possibly be covered by other solutions residue for the surgical use." per ifu the following warning and precaution are stated: 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.Apart from procedural and anatomical factors based on the case details, this complaint was associated to a non-conformance for further investigation.There was a case of wire wrap around the trapliner half pipe.This device was sent for testing,which concluded that an abundance of the biological deposits from the surgical use of this device was present.Scar was issued to supplier to implement update to cleaning process.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 11638152
• Report Number: 2134812-2021-00026
• Device Sequence Number: 3657503
• Product Code: DQY
• UDI-Device Identifier: 10841156102128
• UDI-Public: (01)10841156102128
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: 06/05/2022
• Device Model Number: 5566
• Device Catalogue Number: 5566
• Device Lot Number: 674755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1