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	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no product returned to vsi for evaluation.A manufacturing record review was completed and zero nonconformances were found.Based on the event description the most likely root cause was damage during use.
Event or Problem Description
Langston catheter was used through a 6 fr sheath in the radial artery.Patient developed severe arterial spasm during removal of the langston.Langston became locked in the radial artery in the forearm area due to the severe spasm.Several attempts to remove it were made.Patient was also given nitro, versed and fentanyl to try to reduce the spasm.Upon final attempt to remove the langston, the catheter broke and the tip remained lodged in the radial artery.Patient was subsequently transferred to surgery for foreign body removal.

• 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: 7095640
• Report Number: 2134812-2017-00105
• Device Sequence Number: 16452483
• Product Code: DQO
• UDI-Device Identifier: M20655400
• UDI-Public: M20655400
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/15/2019
• Device Model Number: 5540
• Device Lot Number: 612162
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2016
• Initial Report FDA Received Date: 12/07/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention