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

Model Number	9004
Medical Device Problem Codes	Material Rupture (1546); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiration date: 09/2020.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 or Problem Description
It was reported that during an angioplasty procedure of a highly calcified target legion, the drug-coated balloon allegedly ruptured at 6 atm.It was further reported that another balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review revealed this is the only complaint for corporate lot number.The dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned to the manufacturer for evaluation.The returned sample analysis provided reasonable evidence that a material rupture was not present.The returned sample analysis revealed the balloon was pleat and folded tightly to the inner lumen and the drug coating was no longer visibly present.The catheter's balloon was inflated to 8 atms maintaining a normal shape and pressure.Therefore, the returned sample analysis does provide reasonable evidence that a material rupture was not present.Therefore the investigation is unconfirmed for the reported issue.The root cause of the material rupture could not be determined based upon the available information received from field communications and the returned sample analysis.Labeling review: instructions for use 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.H10: d4 (expiration date: 09/2020),g4,h6(method; 4111) h11: h6(device,method, result 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.
Event or Problem Description
It was reported that during an angioplasty procedure of a highly calcified target legion, the drug-coated balloon allegedly ruptured at 6 atm.It was further reported that another balloon was used to complete the procedure.There was no reported patient injury.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON DILATATION CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 10453075
• Report Number: 3006513822-2020-00027
• Device Sequence Number: 3345479
• Product Code: PRC
• UDI-Device Identifier: 00801741122736
• UDI-Public: (01)00801741122736
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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 Model Number: 9004
• Device Catalogue Number: LX35754405F
• Device Lot Number: GFBV4109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1