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

Model Number 9004

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/07/2023

Event Type  Injury  

Event Description

It was reported that during an angioplasty procedure for stenosis of the superficial femoral artery distally at the junction with the popliteal artery, the balloon was to be pulled back into the airlock, it got stuck at the airlock entrance and could not be completely deflated.It was further reported that when the balloon catheter was again attempted to be pulled back into the airlock, the balloon allegedly ruptured.Reportedly the vessel was punctured in left femoral artery retrograde to remove the remaining material.The current status of the patient is unknown.

Manufacturer Narrative

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.The investigation of the reported event is currently underway.(expiry date: 05/2025).Device pending return.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one lutonix 035 drug coated balloon catheter detached in two segments was received for evaluation.Segment one included the y-body, strain relief and kinked catheter shaft with exposed inner guidewire lumen that was stretched.Segment two included the remaining stretched inner guidewire lumen with balloon that had twisting throughout and was prolapsed at its distal end.No functional testing was performed due to the condition of the sample.Therefore, the investigation is confirmed for the reported detachment and sheath removal difficulty as the device was received detached, with the balloon prolapsed at its distal end which would have occurred due to difficulty removing through the sheath.However, the investigation is inconclusive for the reported balloon rupture and deflation issue as functional testing could not be performed due to the condition of the device.A definitive root cause for the reported balloon rupture, sheath removal difficulty, deflation issue and detachment could not be determined based upon the provided information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: b5, d4 (expiry date: 05/2025), g3.H11: h6 (method, result, conclusion).  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 : see h10.

Event Description

It was reported that during an angioplasty procedure in the superficial femoral artery distally at the junction with the popliteal artery via right common femoral artery, the drug-coated balloon allegedly ruptured and remained in the sheath.It was further reported that the balloon was pulled back into the airlock, it got stuck at the airlock entrance and could not allegedly be completely deflated.It was also reported that the shaft allegedly tore off of the balloon.Reportedly, the vessel was punctured in left femoral artery retrograde to remove the remaining material.The current status of the patient is unknown.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA 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: 16579142
• MDR Text Key: 311647413
• Report Number: 3006513822-2023-00013
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741166853
• UDI-Public: (01)00801741166853
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9004
• Device Catalogue Number: 9090413500080
• Device Lot Number: GFGQ1127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention