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

Model Number	5566
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no product returned for this complaint.No product evaluation was completed for this complaint.Based on the event description that the trapliner 'snapped', it seems possible that the catheter separated at the weld joint proximal to the rapid exchange lumen.However, with no product returned and limited information from the customer due to covid-19 restrictions, the failure mode and root cause cannot be confirmed.
Event or Problem Description
It was reported that the trapliner snapped while not under any pressure with the physician.No further complications were reported.Multiple attempts were made to receive additional information but were unsuccessful.Associated to mdr 2134812-2020-00032 trapliner.
Additional Manufacturer Narrative
One unit of trapliner model 5566 was returned to vsi.On inspected product, minor blood particulates were noted near the distal tip.Damage of the catheter shaft of the half pipe was noted.The lumen of the catheter delaminated from the push rod.A small layer of polymer was wrapped on the push rod near the proximal section of the half pipe.A wavy appearance was observed on the collar of the half pipe.The catheter meets specification.No other damage was seen along the length of the catheter.The lot device history lor was reviewed.There are no nonconformances related to this reported issue therefore supporting the device met material, assembly and performance specifications.Per ifu "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." however, without the confirmation from the account, it is undeterminable.

• Brand Name: TRAPLINER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis, mn
• MDR Report Key: 9939270
• Report Number: 2134812-2020-00031
• Device Sequence Number: 11304739
• Product Code: DQY
• UDI-Device Identifier: 20841156102125
• UDI-Public: (01)20841156102125
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: 02/05/2022
• Device Model Number: 5566
• Device Lot Number: 667070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR