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

Model Number 5566

Device Problem Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing record was reviewed, there were no nonconformance related to this lot, therefore, supporting the device met material, assembly and performance specifications.A follow-up report will be issued after the investigation is complete.

Event Description

As reported: tip broke off being inserted into patient.Used another devices with no issues.No patient injury reported.No medical intervention reported.

Manufacturer Narrative

Device returned for investigation.The device lot history record review indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications prior to shipment.The event description states that the tip broke off before being inserted into the patient.The account stated that it is unknown if the catheter was broken in the package or after it was removed from the package.Upon inspection of evaluation device, no blood particulates were found on the catheter.The weld joint break was confirmed.The tip of the catheter was intact, and no damages were found.The likely cause of weld joint break could be use related during preparation and handling.Per ifu, a warning and precaution are stated as of the following: 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 unintended use error.

• Brand Name: TRAPLINER
• Type of Device: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 10514294
• MDR Text Key: 206784478
• Report Number: 2134812-2020-00060
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20841156102125
• UDI-Public: (01)20841156102125
• Combination Product (y/n): N
• PMA/PMN Number: K161901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2022
• Device Model Number: 5566
• Device Lot Number: 669471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 103