MAUDE Adverse Event Report: LANGSTON V2; DUAL LUMEN CATHETER

Model Number	5540
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be issued after the investigation is complete.
Event or Problem Description
Per received medwatch (b)(4).Tfx report (b)(4).The langston catheter draws back air while in the patient.Upon examination, there is a hole near the hub.No medical intervention reported.No complicatons reported.Additional information received 08oct2020: from procedural notes: a 6-french sidearm via modified seldinger technique to both right cfa and cfv.Ports flushed and aspirated well.Selective coronary angiography performed with 6-french preformed catheter.The catheter with a soft straight wire was required to cross the calcific aov, after about 10 min and catheter flushed every 2 min, then fell into the left ventricle exchanged for langston for left ventricular pressures and subsequent left heart pull back.Ventriculogram was performed in the thirty degree rao.Then exchanged the right cfv sheath with catheter over a jwire and anchored in position w/2 silk sutures.Then exchange the right cfa sheath for iabp sheath and over jwire advanced to bulb under fluoro and set at 1:1 with augmented sbp 140; all sheath and catheters removed.Sheath was sutured in place.
Additional Manufacturer Narrative
A manufacturing record review was completed and no related nonconformances were found.A returned product evaluation was completed.The langston catheter had a kink in the midshaft.The stopcock was separated from the ao port tubing.Adhesive and fillet are present suggesting the bond was completed correctly during manufacturing.There was no other damage present.

• Brand Name: LANGSTON V2
• Common Device Name: DUAL LUMEN CATHETER
• MDR Report Key: 10755788
• Report Number: 2134812-2020-00084
• Device Sequence Number: 16955537
• Product Code: DQO
• UDI-Device Identifier: 10841156100513
• UDI-Public: (01)10841156100513
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: 11/20/2021
• Device Model Number: 5540
• Device Catalogue Number: 5540
• Device Lot Number: 662903
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/10/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 66