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

Model Number	5540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Langston v2 catheter was returned for evaluation.A manufacturing record review was completed and zero nonconformances were found.When internal investigation is complete, a follow-up report will be submitted.
Event or Problem Description
Underlying conditions of the patient, combined aortic valve vitium in moderate aortic valve stenosis and aortic valve insufficiency, severe coronary sclerosis, severe pelvic leg artery kinking.Nurse reported that the tip of the catheter was torn off during procedure and was flushed through the circulatory system into the groin under fluoroscopy and could be secured and removed by the senior physician at this position.A larger sheath was placed, then fixed by a lasso catheter and then removed from the groin together with the sheath.Patient is reported as doing fine.
Additional Manufacturer Narrative
One-unit langston was returned for evaluation.The distal tip of the catheter was separated.The pebax sleeve was present on the separated tip.The distal shaft and the tip were not fully bonded together.The unit was reassembled by sliding the distal shaft back into the pebax overlay and butted up to the proximal side of the tip section.The pebax overlay was loose around the distal shaft, when reassembled.A kink was present in the catheter midshaft.An internal capa has been issued to this complaint.It has been determined that the fusing process did not attain its required time/temp profile for complete fusing to occur.This is the only tip separation failure for this product line in its lifetime.

• Brand Name: LANGSTON V2
• Common Device Name: DUAL LUMEN
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 9088314
• Report Number: 2134812-2019-00064
• Device Sequence Number: 16725318
• Product Code: DQO
• UDI-Device Identifier: 10841156100513
• UDI-Public: (01)10841156100513
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K051395
• 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,Followup
• Report Date (Section B): 08/23/2019

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: Health Professional
• Device Expiration Date: 06/24/2021
• Device Model Number: 5540
• Device Catalogue Number: 5540
• Device Lot Number: 651920
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention