MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC TRAPLINER CATHETER

Model Number	5568
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned product evaluation confirmed the damage to the catheter.The manufacturing records were reviewed and there are no nonconformances related to this lot.There was no material missing from the catheter.It was determined that the damage was not related to manufacturing and was most likely caused by use.The case the root cause for this failure is undeterminable.
Event or Problem Description
Physician pulled out the trapliner 8f after having some resistance during awe cto case, and found that the half pipe has pulled away from the hypotube, however not detached.Physician discovered the half pipe pulled away after removing the device out of the patient.

• Brand Name: TRAPLINER CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7087293
• Report Number: 2134812-2017-00104
• Device Sequence Number: 19048627
• Product Code: DQY
• UDI-Device Identifier: M20655680
• UDI-Public: M20655680
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2017

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: Physician
• Device Expiration Date: 05/25/2019
• Device Model Number: 5568
• Device Lot Number: 608219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 12/06/2017
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 123