MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC LANGSTON V2; DUAL LUMEN

Model Number	5540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record review was completed and zero nonconformances were found.This event is related to mdr 2134812-2017-00090.No patient impact or injury was reported for either of these complaints.The unit for this complaint was sent to the supplier for further investigation.These complaints are under further investigation.A follow-up report will be initiated if additional or further information is received.
Event or Problem Description
During the procedure experienced air drawing back from the engaged catheter while flushing and prepping to zero the line.An unusual blue segment of catheter was noted to be extending from the yellow segment of the catheter.The catheter was removed and another langston was used successfully to complete the case without incident.No patient impact or injury reported.Mdr 2134812-2017-00090 is associated to this report.
Additional Manufacturer Narrative
This event is related to mdr 2134812-2017-00090 langston v2 and mdr 2134812-2017-00076 langston v2.The returned product evaluation confirmed the hub of the catheter was separated from the strain relief.A leak test was performed on the returned unit and the results show that injecting through the ao (aortic) port produced a leak at the point of separation, between the proximal hub/strain relief bond.Furthermore, a liquid leakage under pressure test was completed on test units.Test results concluded that the most likely root cause for this failure is that a high pressure injection was attempted through the ao port causing the bond to separate.The langston ifu precautions; "do not use the outer lumen for the delivery or infusion of diagnostic, embolic, therapeutic materials or to perform pressure injections of contrast medium into the vascular system as such pressure injections could result in device damage.".

• Brand Name: LANGSTON V2
• Common Device Name: DUAL LUMEN
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 7018110
• Report Number: 2134812-2017-00091
• Device Sequence Number: 1394147
• Product Code: DQO
• UDI-Device Identifier: M20655400
• UDI-Public: M20655400
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017

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: 06/22/2019
• Device Model Number: 5540
• Device Lot Number: 610118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 03/06/2018
• Patient Sequence Number: 1