MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035AV DRUG COATED PTA DILATION CATHETER; DRUG COATED BALLOON PTA CATHETER

Model Number	9010
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 11/2021).
Event or Problem Description
It was reported that during a procedure, the device allegedly did not reach the targeted location.The length of the device was compared with another device labeled to be of the same length and was found to be shorter.The device was allegedly reported to have a labelling issue.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a procedure, the device allegedly did not reach the targeted location.The length of the device was compared with another device labeled to be of the same length and was found to be shorter.The device was allegedly reported to have a labelling issue.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: a sample evaluation was not performed as the device was not returned.However, three electronic photos were reviewed.Photo 1 shows product labeling of the conquest 40 device and the lutonix 035 device.The labeling matches the reported information in the record.Photo 2 and photo 3 show a lutonix 035 device and a conquest 40 device.The lutonix 035 device appears to be different in each photo.The devices are being held out above a table with other equipment.It appears the lutonix devices hub began closer to the distal end of the device than the conquest 40.However, it is unable to be determined if the device is under the necessary specifications based upon the photos as the length of either device is unable to be determined.Therefore based on the photo review, no confirmations can be made and the investigation remains inconclusive for the reported device length issue.A definitive root cause for the reported device length issue could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 11/2021), g3, h6 (method).H11: h6 (result, conclusion).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: LUTONIX 035AV DRUG COATED PTA DILATION CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 11892191
• Report Number: 3006513822-2021-00030
• Device Sequence Number: 19173113
• Product Code: PRC
• UDI-Device Identifier: 00801741135521
• UDI-Public: (01)00801741135521
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• 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): 08/04/2021

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 Model Number: 9010
• Device Catalogue Number: LX35751060V
• Device Lot Number: GFEY1733
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 08/06/2021
• 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: Other