MAUDE Adverse Event Report: LUTONIX, INC. LUTONIX® DRUG COATED BALLOON; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number LX1813053005F

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

Patient had 100% occlusion of the left superficial femoral artery (sfa); it was very calcified.With a 5-french destination sheath positioned in the right and left femoral arteries, and a navicross catheter, doctor was able to cross the 100% lesion with a wire and do runoff.Then he exchanged that wire for a 0.014 viperwire, and using cleaning devise 1.8 did an atherectomy; he followed that with a 4.0 balloon at high pressure for a few seconds.Then he tried to insert the drug-eluting balloon, but it would not go far enough in.He then decided to exchange the wire for a 0.018 wire.As he was pulling the balloon back, about halfway into the sheath, the shaft broke off and then a part of the shaft was out; however, the balloon remained in the sheath.Cath lab time was extended due to multiple attempts to get it out, including trying to snare it.What finally worked was putting a 0.018 wire in the sheath next to the retained shaft, then inflating a 2.0 balloon and then pulled the whole thing out as a unit.Md described the drug-eluding balloon shaft as "fractured." registered nurse stated that the balloon tip sheared off the balloon shaft.

• Brand Name: LUTONIX® DRUG COATED BALLOON
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): LUTONIX, INC.
• MDR Report Key: 15619174
• MDR Text Key: 301909521
• Report Number: 15619174
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2022

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: LX1813053005F
• Device Catalogue Number: LX1813053005F
• Device Lot Number: GFGN1384
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30660 DA
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Race: White