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

Model Number 9004

Device Problems Break (1069); Crack (1135)

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

Event Date 08/30/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2026).H11: section a through f ¿ the information provided 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.H3 other text : device pending return.

Event Description

It was reported that prior to an angioplasty procedure, the distal plastic part of the balloon where the inflator connects allegedly broke.There was no patient contact.

Manufacturer Narrative

H10: 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 (expiration date: 05/2026).H11: h6 (device).H11: section a through f ¿ the information provided 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.H3 other text: device pending return.

Event Description

It was reported that prior to an angioplasty procedure, the distal plastic part of the balloon where the inflator connects was allegedly fractured.There was no patient contact.

• Brand Name: LUTONIX 035 DRUG COATED PTA DILATATION CATHETER
• Type of Device: DRUG COATED BALLOON PTA 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: 17829100
• MDR Text Key: 324407944
• Report Number: 3006513822-2023-00034
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/15/2023

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: 9004
• Device Catalogue Number: 9090413400150
• Device Lot Number: GFHQ0181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 01/05/2024
• 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