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

Model Number	9014
Medical Device Problem Codes	Crack (1135); Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the superficial femoral artery via the left anterior tibial access, there was difficulty in removing the outer covering of the drug coated balloon catheter.It was further reported that the balloon allegedly would not easily pass through the sheath.It was also reported that once the balloon was delivered to the desired location and inflated, the balloon allegedly ruptured at the nominal pressure.Furthermore, there was difficulty in retracting the balloon through the introducer sheath.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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.H10: d4: (expiration date: 03/2026).H11: section a: through f: the information provided by bd represents all 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.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one lutonix 018 drug coated balloon catheter was returned for evaluation.No specific anomalies were noted during the visual evaluation.In the functional testing, the balloon was inflated with the presto inflation device and water leakage was observed on the balloon.Under microscopic observations, a compound balloon rupture was observed.Furthermore, the catheter was attempted to advance an in-house guide wire, but it was unsuccessful due to the device's condition returned for evaluation.Resistance was also felt in the attempt to insert the guide wire.Under microscopic observation, dried residue/contrast was observed on the inflation luer and a crack was also observed on the inflation luer.No further testing could be done.During the microscopic observation of the returned catheter, a compound balloon rupture was noted and a crack on the inflation luer was observed.Functional testing couldn¿t be performed fully for all other allegation due to the condition of the device.Hence, the investigation was confirmed for the reported balloon rupture and identified crack.However, the investigation for the remaining reported difficulty with advancement of the catheter over the sheath, difficulty in removing the catheter from the and introdcuer sheath, difficulty removing the balloon protector from the balloon remains inconclusive.However, the definitive root cause for the reported balloon rupture, difficulty with advancement of the catheter over the sheath, difficulty in removing the catheter from the introducer sheath, difficulty removing the balloon protector from the balloon and identified crack on the luer could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 03/2026).H11: section a through f ¿ the information provided by bd represents all 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 in the superficial femoral artery via the left anterior tibial access, there was difficulty in removing the outer covering of the drug coated balloon catheter.It was further reported that the balloon allegedly would not easily pass through the sheath.It was also reported that once the balloon was delivered to the desired location and inflated, the balloon allegedly ruptured at the nominal pressure.Furthermore, there was difficulty in retracting the balloon through the introducer sheath.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: LUTONIX 018 DRUG COATED DILATATION CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18593915
• Report Number: 3006513822-2024-00005
• Device Sequence Number: 6810512
• Product Code: PRC
• UDI-Device Identifier: 00801741177637
• UDI-Public: (01)00801741177637
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: 9014
• Device Catalogue Number: LX1813052205F
• Device Lot Number: GFHN1849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Race: White