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

Model Number 9004

Device Problem Retraction Problem (1536)

Patient Problem Injury (2348)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 08/2020).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.

Event Description

It was reported that during an angioplasty procedure in left superficial femoral artery via ipsilateral approach, the drug-coated balloon allegedly became stuck in the sheath upon removal.It was further reported that the physician lost access after removing the device.The physician used another pinnacle sheath to regain access and complete the procedure.Patient status is unknown.

Event Description

It was reported that during an angioplasty procedure in left superficial femoral artery via ipsilateral approach, the drug-coated balloon allegedly became stuck in the sheath upon removal.It was further reported that the physician lost access after removing the device.The physician used another pinnacle sheath to regain access and complete the procedure.Patient status is unknown.

Manufacturer Narrative

Manufacturing review: the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the returned sample analysis confirmed the occurrence of a retraction issue through the introducer sheath.The distal portion of the balloon is severely wrinkled.The proximal portion of the cook introducer sheath immediately distal to the hemostasis valve is accordioned.The middle portion of the introducer sheath is accordioned.The distal portion of the introducer sheath is intermittently overlapped with the distal tip of the introducer sheath pushed into the inner lumen of the introducer sheath.In the middle of the introducer sheath the outer surface has been damaged in a single location, the damage is representative of forceps.It was reported the health care professional (hcp) used an ipsilateral antegrade approach with a 5 french cook raabe introducer sheath over an 035 bentson guidewire to treat the target lesion in the proximal popliteal artery.After a successful target lesion treatment, the hcp deflated the lutonix dcb with a presto device, filled with 50/50 contrast/saline solution.The hcp waited approximately 2 minutes, while the presto device read negative pressure and confirming the lutonix dcb was completely deflated under fluoroscopy.After 2 minutes, reportedly, the hcp withdrew the lutonix dcb from the target lesion and allegedly after entering the cook introducer sheath the lutonix dcb, became stuck.The hcp removed the introducer sheath and the lutonix dcb as a single unit, and expressed that patient access was lost.The hcp reportedly used a pinnacle introducer sheath to regain patient access and complete the procedure.There were no other drug coated products used during the procedure.The root cause of the retraction issue though the introducer sheath could not be determined based upon the available information.Labeling review: instructions for use states in section 12.6 use of lutonix catheter step 7 -9 states "apply negative pressure to fully deflate the lutonix® catheter.Prior to removal, confirm that the balloon is fully deflated under fluoroscopy.Withdraw the lutonix catheter from the body under negative pressure.Maintain the guidewire access across the stenosis.H10: d4 (expiration date: 08/2020), g4, h6(method: 3331).H11: h6(method, results and 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.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 10153200
• MDR Text Key: 195103857
• Report Number: 3006513822-2020-00017
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741123306
• UDI-Public: (01)00801741123306
• Combination Product (y/n): N
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• 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: LX3513061505F
• Device Lot Number: GFBV1955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 59