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

Model Number	5540
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The most likely cause of the reported event, based on this analysis is that the "inner" burst during high pressure injection and allowed the high pressure to exert on the strain relief, causing the strain relief to burst as well.Additional investigation is in progress.A follow-up report will be submitted.
Event or Problem Description
During the lv power injection, the yellow tubing at the hub of the catheter fractured.900 psi was used for the injection.Another langston catheter was used to complete the procedure without further incident.Reference mdr 2134812-2017-00074 for associated report.
Additional Manufacturer Narrative
Mdr2134812-2017-000073.This device was returned and investigated -(also reference mdr-2134812-2017-00074, device did not return).Evaluation of this device confirmed the catheter strain relief tore during use.Dissection of the catheter revealed that the inner catheter had a longitudinal rupture approximately 2.5 inches distal to the strain relief, which likely occurred during high pressure injection and resulted in pressure build up in the strain relief area until the strain relief tore.The location of the longitudinal rupture is in an area of the inner catheter where no further manufacturing processes are performed.The component supplier investigated the returned unit and was unable to identify a cause for the longitudinal rupture.The component supplier provided test data for the burst pressure of the inner catheter shafts showing that their process is capable of meeting the burst pressure requirement.The supplier did not indicate any deviations on this lot or trend of similar events.

• 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: 6900588
• Report Number: 2134812-2017-00073
• Device Sequence Number: 566559
• 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): 09/01/2017

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: 02/15/2019
• Device Model Number: 5540
• Device Lot Number: 604198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 02/13/2018
• Patient Sequence Number: 1