MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. LUTONIX 035AV DRUG COATED PTA DILATION CATHETER; DRUG COATED BALLOON PTA CATHETER

Model Number	9010
Medical Device Problem Codes	Difficult to Insert (1316); Material Separation (1562); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
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.The investigation of the reported event is currently underway.(expiry date: 10/2021).
Event or Problem Description
It was reported that during a procedure through the upper arm fistula to treat stenosis through an antegrade approach, the device allegedly failed to advance over the guidewire.It was further reported that the procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one lutonix 035 av drug coated pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device appeared clean and no other specific anomalies were noted.On the functional evaluation, the guide wire lumen was flushed using an in-house syringe but only the minimal water exited out of the distal tip.On further the guidewire was inserted into the distal tip, it was noted there was a resistance when advancing the guidewire.Retraction of the catheter was not possible since resistance was major and the guidewire was able to advanced fully, however an opaque material was noted on the tip of the guidewire when it exited out of the guidewire port.The opaque material was present throughout the length of the guidewire.Then the thin material was removed and it was examined under the microscope.No further functional testing was conducted.The investigation is confirmed for the reported difficult to insert and device-device incompatibility, as the guidewire felt resistance during the insertion.The investigation is confirmed for identified material separation, as the device was noted to have the opaque material at the guidewire port during the withdrawal of the guidewire.A definitive root cause for the reported difficult to insert, device-device incompatibility and the identified material separation could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: b5, d4 (expiry date: 10/2021), g3, h6 (method).H11: h6 (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.H3 other text : see h10.
Event or Problem Description
It was reported that during a procedure through the upper arm fistula to treat stenosis through an antegrade approach, the device allegedly failed to advance over the guidewire.It was further reported that the device allegedly difficult to insert.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: LUTONIX 035AV DRUG COATED PTA DILATION CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11861555
• Report Number: 3006513822-2021-00027
• Device Sequence Number: 1009651
• Product Code: PRC
• UDI-Device Identifier: 00801741187698
• UDI-Public: (01)00801741187698
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 9010
• Device Catalogue Number: LX3575780V
• Device Lot Number: GFEX1046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 04/24/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other