MAUDE Adverse Event Report: LANGSTON DUAL LUMEN; DUAL LUMEN CATHETER

Model Number	5550
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be issued after the investigation is complete.
Event or Problem Description
As reported: performing aortic valve study using a 6f radial access.Aortic port would persistently aspirate air and blood when in body.Blood leakage was noted at the hub.No injections performed, power or otherwise.Upon removal of the catheter the inner catheter became detached from the outer layer of the catheter lumen.All of the catheter was retrieved from the patient without incident.It was not completely detached and came out manually over a wire.
Additional Manufacturer Narrative
A returned product evaluation was completed.Lot and case details were reviewed.The event description states aortic port would persistently aspirate air and blood when in body.Blood leakage was noted at the hub.Upon removal of the catheter, the inner lumen detached from the outer layer/lumen.Separation of the inner and outer lumen was confirmed.No adhesive was observed under the strain relief.No other damages were noted on the shafts of both inner and outer lumen.Additional information was requested from the account.A response was received.Account stated that all of the catheter was retrieved from the patient without incident.The outcome of the procedure was good and completed with alternative equipment.No patient injury observed.Based on the product evaluation, there is likely a bond issue between the distal strain relief and the outer lumen due to a manufacturing/process deficiency.A non-conforming (nce) was initiated to investigate.Nce concluded that the root cause was undeterminable but through process review it was noted that the cleaning step for the strain relief does not specify the full length of the strain relief which could have contributed to a weaker bond if the strain relief was not thoroughly cleaned.Langston devices were removed from field through z-1747-2020 and z-0112-2021.Customer was confirmed to be in scope and was communicated multiple times for return.The scope of the internal corrective action related to the recall includes updates to the manufacturing process.

• Brand Name: LANGSTON DUAL LUMEN
• Common Device Name: DUAL LUMEN CATHETER
• MDR Report Key: 11453010
• Report Number: 2134812-2021-00015
• Device Sequence Number: 19737679
• Product Code: DQO
• UDI-Device Identifier: 30841156100531
• UDI-Public: (01)30841156100531
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

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: Health Professional
• Device Expiration Date: 10/08/2021
• Device Model Number: 5550
• Device Lot Number: 659555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 07/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1747-2020_Z-0112-2021
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 121