MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 014 RX SFA DRUG COATED BALLOON DILATION CATHETER; DRUG COATED PTA BALLOON CATHETER

Model Number 9008

Device Problems Inflation Problem (1310); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiry date: 07/2025).H11: section a through f - the information provided by bd represents all of 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.

Event Description

It was reported that during an angioplasty procedure, the drug coated balloon allegedly got twisted upon inflation at nominal pressure.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the drug coated balloon allegedly got twisted upon inflation at nominal pressure.There was no reported patient injury.

Manufacturer Narrative

H10: additional information was received and as this device or a similar device has not been cleared for marketing or commercial distribution in the united states, the event does not meet the criteria of a reportable event.Therefore, the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiry date: 07/2025), g3 h11: d1, d4 (medical device catalogue number) h11: section a through f - the information provided by bd represents all of 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.H3 other text : device not returned.

• Brand Name: LUTONIX 014 RX SFA DRUG COATED BALLOON DILATION CATHETER
• Type of Device: DRUG COATED PTA BALLOON CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17807875
• MDR Text Key: 324148636
• Report Number: 3006513822-2023-00033
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741224928
• UDI-Public: (01)00801741224928
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 9008
• Device Catalogue Number: LX1415061005FX
• Device Lot Number: GFGS2727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/25/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1