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

Model Number	5567
Medical Device Problem Codes	Device Damaged by Another Device (2915); Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trapliner was returned to vsi/teleflex for evaluation.Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore supporting the device met material, assembly and performance specifications.Blood particulates were found along the length of the catheter.Separation of the half-pipe lumen from the hypotube push rod was noted.The collar transition had minor damage.No tip damage was observed.No other damage was noted on the catheter.A follow-up report will be issued after the investigation is complete.
Event or Problem Description
An email received from the customer reported that they had a case where they had a stent catch on the trapliner and the shaft broke away from the tubing.No further complications were reported.
Additional Manufacturer Narrative
The separation was a longitudinal tear seen at the bottom of the half pipe.The collar transition had minor damage.The damage includes several minor depressions indicating a device interaction that could have been pushed against resistance.Minor bends were noted on the hypotube.No tip damage was observed.The catheter was tested and it met specifications.The damages may have occurred due to concomitant device (stent system) interaction with the trapliner during advancement or retrieval of the device against resistance and/or torqueing of the device.It was confirmed that the device got caught on the way in either at the beginning of the hypotube or inside the trapliner.Per ifu: 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.Based on the information and returned product evaluation, the most likely root cause of the issue is operational context and/or unintended use error.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneaplois, mn
• MDR Report Key: 10257704
• Report Number: 2134812-2020-00040
• Device Sequence Number: 2432807
• Product Code: DQY
• UDI-Device Identifier: 20841156102132
• UDI-Public: (01)20841156102132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2020

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: 03/02/2022
• Device Model Number: 5567
• Device Lot Number: 668743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 101