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

Model Number	5515
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received voluntary medwatch from site.Details of event as documented in this report was submitted by site.Device return was requested.If device sample returns, a follow-up report will be submitted.The event description stated, there was extreme tortuosity and severe calcification of the arteries.The catheter had snapped off at the neck while inside the patient.All the pieces of the catheter were removed within the sheath system and there was no patient impact.The record review shows that there were zero nonconformances during manufacturing.There was no returned product to complete an evaluation.The most likely root cause for this failure is damage during use.
Event or Problem Description
During cardiac catheterization procedure, upon pullback of the wire, a snapping was felt.The wire was able to be pulled completely out, however, noted that the dual lumen catheter had snapped at the neck area.Some pieces had prolapsed within the catheter while other pieces were retained within the long sheath.Upon further examination, all pieces of the catheter were found.In addition, fluoroscopy procedures done which did not identify any retained fragments in the patient.No adverse outcome to the patient.Pt had extreme tortuosity and severe calcification of bilateral iliac arteries and also entire aorta.Peripheral vascular disease, severe aortic stenosis and history of 3 vessel cabg in 2008.

• Brand Name: LANGSTON
• Common Device Name: DUAL LUMEN CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 6435991
• Report Number: 2134812-2017-00034
• Device Sequence Number: 13603816
• Product Code: DQO
• UDI-Device Identifier: M20655150
• UDI-Public: +M20655150/$$31807185965516
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 07/18/2018
• Device Model Number: 5515
• Device Lot Number: 596551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/27/2017
• Patient Sequence Number: 1
• Patient Weight: 73