MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number 9004

Device Problems Deflation Problem (1149); Material Perforation (2205)

Patient Problem Injury (2348)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

Analysis: the sample discarded by the user facility; therefore, a device evaluation is unable to be performed.A lot history review or a device history record (dhr) were unable to be completed because the lot number or product catalog number were not provided by the user facility.Conclusion: the actual sample was not received for evaluation.The dhr was not performed because the product identifiers are unknown.It was reported after inflating the lutonix dcb for 10 seconds to 10 atmospheres, the hcp noticed an irregular heart rhythm on the patient's monitor.Reportedly, the guidewire started to migrate toward the patient's heart.The hcp attempted to withdraw the guidewire while the lutonix dcb was inflated resulting in resistance.The hcp continued treating the target lesion for 2 minutes at 10 atms.While attempting to deflate, the lutonix dcb could not deflate.The hcp attempted to deflate with a 10cc syringe, but no contrast aspirated.It is unknown if the hcp applied negative pressure prior to use of the device or during advancement to the target lesion.The balloon was punctured, using ultrasound guidance with an 18 gauge needle, to remove lutonix dcb from the patient.The hcp reportedly noticed a hole between the inflation port and the catheter shaft.The dcb was completely removed and discarded.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.

Event Description

It was reported that during an angioplasty procedure, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly was difficult to deflate while treating the in-stent target lesion in the cephalic arch of the inflow tract of the av fistula.The health care professional (hcp) pre-dilated the target lesion with an atlas percutaneous transluminal angioplasty (pta) balloon.The hcp delivered the lutonix dcb over a terumo glidewire through a 10 french introducer sheath to the intended treatment site.The physician noted that there was a covered fluency stent near the intended treatment site.After successfully delivering the lutonix dcb to the intended treatment site and inflating the lutonix dcb for 10 seconds at 10 atmospheres (atms) with an indeflator, the physician reported that the patient had an irregular heart rhythm.Reportedly, the guidewire was migrating toward the patient's heart.The physician attempted to withdraw the terumo glidewire, while the lutonix dcb was inflated, and encountered resistance.The hcp decided not to pull any further as the patient's irregular heart rhythm had stopped.The physician continued treating the vessel for two minutes at 10 atms.After completing the treatment, the physician released the indeflator to deflate the lutonix dcb, but the lutonix dcb would not deflate.Then the physician attempted to deflate the balloon with a 10cc syringe, but no visapaque contrast aspirated.The physician then decided to use ultrasound guidance to puncture the lutonix dcb with an 18 gauge needle.The deflated lutonix dcb was removed and examined by the hcp.The hcp reportedly noticed a hole between the inflation port and catheter shaft.The physician has taken a picture of the hole, but was unable to send it due to size of image file.The sample was discarded by the user facility.No adverse events have been reported.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: mike gaffney ; 9409 science center dr; new hope, MN 55428 ; 7634458639
• MDR Report Key: 8370210
• MDR Text Key: 137373626
• Report Number: 3006513822-2019-00027
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• 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: UNK SFA 035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/29/2019
• 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
• Patient Outcome(s): Required Intervention