MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 018 DRUG COATED BALLOON PTA CATHETER; DRUG COATED BALLOON CATHETER

Model Number	9014
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 01/2021).
Event or Problem Description
It was reported that during an angioplasty procedure in the left superficial femoral artery via left femoral approach, the drug coated balloon allegedly ruptured at 12atm.The balloon was exchanged over the guidewire for another that was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure of a calcified lesion in the right superficial femoral artery via left femoral approach.The lesion site was pre-dilated with an 018 pta balloon.The drug coated balloon allegedly ruptured at 12atm during the first inflation attempt.The balloon was exchanged over the guidewire for another that was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned by the facility for further evaluation.It was reported the health care professional (hcp) treated a calcified lesion in the right superficial femoral artery using a contralateral approach from the left femoral artery.The hcp gained access with a 6 french fortress introducer sheath over and 018 advantage glidewire.The hcp prepared the target lesion by pre-dilating the desired location with an 018 pacific plus.After the pacific plus was removed, the hcp reportedly advanced the lutonix dcb to the target lesion and inflated the balloon up to 12 atmospheres(atms).Allegedly, the moment the hcp reached 12 atms on the indeflator, the balloon reportedly ruptured.The hcp successfully removed the device from the patient and used an additional 2 lutonix dcbs to complete the procedure.No adverse patient outcomes were reported.The root cause of the material rupture could not be determined based upon the available information received from field communications.Labeling review: in ifu baw1436700 states in section 8 " potential adverse events which may be associated with a peripheral balloon dilatation procedure lists rupture as a potential adverse event.Section 5.4 device use/ procedure precautions states predilatation with uncoated pta catheter is required prior to use of lutonix catheter always advance and retrieve the lutonix catheter under negative pressure.Whenever possible, the lutonix catheter should be the final treatment of the vessel, however post dilatation is allowed with another pta catheter or the previously used lutonix catheter.Section 12.6 use of lutonix catheter step 4 states while the balloon is fully deflated and under negative pressure, advance the dcb through the introducer sheath and over the wire to the site.Section 3 states the safety and effectiveness of lutonix catheter have not been established for treatment in cerebral, carotid , coronary or renal vasculature.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 018 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 9701145
• Report Number: 3006513822-2020-00001
• Device Sequence Number: 16579935
• Product Code: ONU
• UDI-Device Identifier: 00801741177705
• UDI-Public: (01)00801741177705
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: 9014
• Device Catalogue Number: LX1813062205F
• Device Lot Number: GFDQ0922
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1