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

Model Number	9014
Medical Device Problem Codes	Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure through the groin femoral to treat the sfa via a contralateral approach, the balloon allegedly twisted upon inflation.It was further reported that balloon was removed form patient and tried to insert again, however, the balloon was allegedly unable to insert.There was no reported patient injury.
Additional 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 not been returned to the manufacturer for evaluation.However, a photo and image were provided for review.The investigation of the reported event is currently underway.Expiry date: 04/2023.
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: the physical device was not returned for evaluation.One medical image was reviewed.A fluoroscopy image is reviewed showing the lutonix 018 balloon inflated along a segment likely of the left superficial femoral artery.Towards the bottom of the screen it appears that a small portion of the balloon is not inflated, which is a represented by a small ¿waist¿ or narrowing of the balloon.Based on the image review, material twisted can be confirmed.However difficult to insert is kept inconclusive.One photo was provided and reviewed.The photo shows the lutonix 018 balloon which appears bloody.No twisting is seen on the balloon.No other specific anomalies noted.Therefore, material twisted and difficult to insert is kept inconclusive based on the submitted photo.Therefore, the investigation is confirmed for the reported material twisted since material twisting was noted on the balloon during medical image review.However, the investigation is inconclusive for the reported difficult to insert as no objective evidence was provided for review.A definitive root cause for the alleged material twisted and difficult to insert could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4(expiry date: 04/2023).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.H3 other text : device not returned.
Event or Problem Description
It was reported that during an angioplasty procedure through the groin femoral to treat the sfa via a contralateral approach, the balloon allegedly twisted upon inflation.It was further reported that balloon was removed form patient and tried to insert again, however, the balloon was allegedly unable to insert.There was no reported patient injury.

• Brand Name: LUTONIX 018 DRUG COATED DILATATION CATHETER
• Common Device Name: DRUG COATED PTA BALLOON CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope 55428
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13151450
• Report Number: 3006513822-2021-00061
• Device Sequence Number: 5412258
• Product Code: ONU
• UDI-Device Identifier: 00801741184710
• UDI-Public: (01)00801741184710
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• 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): 01/11/2022

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: LX1813053005F
• Device Lot Number: GFFQ0625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown