MAUDE Adverse Event Report: LUTONIX, INC. LUTONIX ® 035 DRUG COATED BALLOON PTA CATHETER; DRUG-COATED PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number LX3575860V

Device Problems Material Fragmentation (1261); Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2019

Event Type  malfunction  

Event Description

An elderly female patient having done interventional radiology (ir) arteriogram pelvis, right iliac angioplasty with stent placement.Aorta was first ballooned with a 12mm mustang, then ballooned the right common iliac stent with an 8 drug-coated balloon into the aortic stent area.This balloon ruptured.The balloon was extracted but fragmented into segments.After multiple attempts and usage of different devices, the fragments were extracted.Procedure was completed, patient tolerated procedure well and was discharged same day.See physician note below: "we did guide access retrograde right common femoral artery put a glidewire up and gave 5000 units of heparin.Put in a 6 french sheath we then brought in a contra catheter did an aortogram with bilateral iliofemoral imaging that showed stenosis in the aortic stent and bilateral iliac stents worse on the right.We first balloon the aorta with a 12 mm mustang we then ballooned the right common iliac stent with an 8 drug-coated balloon into the aortic stent area.This balloon ruptured.We then able to get the whole balloon extracted out.It then fragmented in the segments.We could still see some parts that were on the wire we could get it off.We tried pointing to the sheath was not coming through there we upsized to a 7 and intervention 8 french sheath but still could not get retract through.We then did ultrasound-guided access retrograde in the left side put in a 6 french sheath there brought in a snare and snare the wire so we had through and through access around.We brought in a kumpe (kmp) catheter and see if were able to push down from above into the 8 french sheath and still could not get this to go.Look like we are working to be able to remove this out so we thought the best option see if we can just stent this and smashed it into the wall.We then brought in 8 x 37 express ld just outside this area and then ballooned or inflated the stent try to pull out the wire part of it was coming out and then it was brought the rest of the balloon with it is just came down i was able to again pulled down through the 8 french sheath and was able to fully extracted.We then brought in to 9 mm mustang's from the bilateral iliac stents through the aortic stent all the way through the top did 2 different inflations with that last for over 2 minutes.We then did a completion aortogram and showed that the aortic stent and bile iliac stent to be much improved with brisk flow through this.We then did a star close on the left with good hemostasis we then switched to a perclose on the right deployed that with good hemostasis as well.He was brought to recovery stable condition.".

• Brand Name: LUTONIX ® 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: DRUG-COATED PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): LUTONIX, INC.; 9409 science center dr; new hope MN 55428
• MDR Report Key: 9109242
• MDR Text Key: 159812906
• Report Number: 9109242
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741135460
• UDI-Public: (01)00801741135460
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LX3575860V
• Device Catalogue Number: LX3575860V
• Device Lot Number: GFCR3700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Weight: 61