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

Model Number	9014
Medical Device Problem Codes	Inflation Problem (1310); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
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 device has been returned to the manufacturer; however the image was provided and the evaluation is still pending.The investigation of the reported event is currently underway.Expiry date (02/2022).
Event or Problem Description
It was reported that during an angioplasty procedure through the sfa, the lutonix balloon allegedly failed to inflate.Imaging examination showed what appeared to be a rubber band wrapped around the balloon.The balloon was removed without issue and upon trying to inflate again, the balloon would not inflate.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure through the sfa, the lutonix balloon allegedly failed to inflate.Imaging examination showed what appeared to be a rubber band wrapped around the balloon.The balloon was removed without issue and upon trying to inflate again, the balloon would not inflate.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the allegation of a twisted balloon was confirmed through review of the returned sample analysis and fluoroscopic imaging, illustrating a portion in the middle of the balloon did not fully inflated while treating the target lesion.The review of fluoroscopic imaging, illustrates a portion in the middle of the balloon did not fully inflated while treating the target lesion.The returned sample analysis revealed the catheter wrinkles and striations approximately 117-125 mm from the distal tip of the catheter.Therefore, the returned sample analysis and the fluoroscopic images illustrates the balloon was unable to fully inflate within side the patient, but was able to inflate to a uniform shape without fluctuations and then deflate completely during evaluation.It was reported the health care professional (hcp) prepared the target lesion in the superficial femoral artery (sfa) with predilation.Reportedly, the lutonix dcb was advanced to the target lesion and attempted to be inflated.During inflation, allegedly the fluoroscopic images displayed what appeared to be a "rubberband wrapped around the balloon" resulting in the inability to inflate the balloon.The hcp removed the lutonix dcb without issues.The hcp reportedly completed the patient's procedure with another non drug coated device.Reportedly, after the lutonix dcb was removed, the hcp attempted to inflate the balloon again but the balloon would not inflate.A definitive root cause could not be determined.Labeling review: 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.H10: g4, d4 expiry date (02/2022).H11: h6 (method, result, 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 018 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED PTA BALLOON CATHETER
• Manufacturer (Section D): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• MDR Report Key: 10287609
• Report Number: 3006513822-2020-00022
• Device Sequence Number: 3623781
• Product Code: ONU
• UDI-Device Identifier: 00801741177637
• UDI-Public: (01)00801741177637
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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: 9014
• Device Catalogue Number: LX1813052205F
• Device Lot Number: GFEQ0690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR