MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 018 DRUG COATED BALLOON PTA CATHETER; DRUG COATED 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	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device for this malfunction has been returned to the manufacturer for evaluation.An image was received for review, which illustrated the middle portion of the balloon was not fully inflated during inflation at the target lesion.The investigation of the reported malfunction is currently underway.The device is labeled for single use.
Event or Problem Description
It was reported that during an angioplasty procedure in the right superficial femoral artery, accessed contralaterally, the balloon allegedly twisted during inflation.No further treatment was needed.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the right superficial femoral artery, accessed contralaterally, the balloon allegedly twisted during inflation.No further treatment was needed.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 allegation of a twisted balloon was confirmed through review of fluoroscopic imaging, which illustrated a portion in the middle of the balloon did not fully inflate while treating the target lesion, and visual analysis of the returned sample, which identified striations, wrinkles in the middle of the balloon.It was reported the health care professional (hcp) used a contralateral approach to gain access to the left superficial femoral artery (sfa) with a 6 french terumo destination introducer sheath over an 035 terumo guidewire.The hcp predilated the target lesion with an ultrascore balloon.The hcp prepared the lutonix dcb in the normal fashion without difficulties removing the balloon protector.The hcp reached the target lesion under negative pressure without rotating the shaft of the catheter, and inflated the lutonix dcb with 50:50 contrast solution to 9 atms using a presto indeflator.Reportedly, the lutonix dcb did not fully inflate and was twisted in the middle.The hcp allegedly indicated that the balloon was moved a few centimeters from the target lesion and the twisted region was seen again.There were no retraction difficulties and the inflation issue was able to be repeated inside the patient.The physician does not believe the anatomy of the patient contributed to the middle portion of the balloon not fully inflating.No adverse patient outcomes were reported.Labeling review: ifu baw1436700r0 states: section 5.4 device use/procedure precautions states: the lutonix® catheter should be advanced to the target lesion as fast as possible (i.E.~ 30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition (balloon to artery ratio = 1:1).Always advance and retrieve the lutonix® catheter under negative pressure.Section 13.6 use of the lutonix® catheter step 4.While the balloon is still fully deflated and under negative pressure, advance the lutonix® catheter through the introducer sheath and over the wire to the site of inflation.During catheter advancement, inspect the catheter shaft for damage.Step 9.Apply negative pressure to fully deflate the lutonix® catheter.Prior to removal, confirm that the balloon is fully deflated under adequate visualization.H10: b3, g4 h11: h3, h6 (results1, conclusion1) 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: 9269496
• Report Number: 3006513822-2019-00132
• Device Sequence Number: 1927568
• Product Code: ONU
• UDI-Device Identifier: 00801741177637
• UDI-Public: (01)00801741177637
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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: 02/25/2021
• Device Model Number: 9014
• Device Catalogue Number: LX1813052205F
• Device Lot Number: GFDQ2537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 81