MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number	9004
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter.Under magnification, a small inverted "v" shaped rupture was found in the balloon, near the distal marker band.The rupture was found within the fold of the balloon.Scratches were noticed at the tip of the rupture.The base on the small "v" shaped material was wrinkled, such that the hole was clearly visible.Functional testing of the complaint sample concluded the small "v" shaped material rupture would not allow the balloon to inflate.A lot history review revealed this is the only complaint associated with this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: returned product analysis confirmed a "v" shaped material rupture was present, near the distal marker band of the catheter.The rupture was found within the fold of the balloon.Scratches were noticed at the tip of the rupture.The base on the small "v" shaped material was wrinkled, such that the hole was clearly visible.The dhr found nothing to indicate a manufacturing related cause for this event.A definitive root cause could not be determined based on the information provided.Reportedly, the sfa zone was narrowed to 70%, but there were no stents in the treatment area or tracking path.If additional relevant information becomes available, a supplement report will be submitted with all relevant information.
Event or Problem Description
It was reported that a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was allegedly unable to inflate because it was "broken".The health care professional (hcp) gained patient access through an ipsilateral approach.Reportedly, the hcp pre-dilated the 70% narrowed, 10cm target lesion in the patient's superficial femoral artery (sfa) with a 4mmx150mm balloon.The patient used a terumo glidewire to deliver the lutonix dcb to the target lesion.Reportedly, there were no stents in the treatment area or tracking path.The physician attempted to inflate the lutonix dcb with a bd presto indeflator, but was unable to.The physician provided a video to illustrate what occurred during the procedure.A review of the video noted the device was leaking body fluid contamination from the inflation hub while applying negative pressure.It also revealed, when the device was removed from the patient, the device was leaking from the end of the catheter while being flushed.The lutonix dcb was removed without issues and another lutonix dcb was used to complete the procedure.The sample was sterilized and cleaned by the user facility.The sample has been returned for further evaluation.No reported patient injury occurred.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 8426872
• Report Number: 3006513822-2019-00045
• Device Sequence Number: 16656931
• Product Code: ONU
• UDI-Device Identifier: 00801741123184
• UDI-Public: (01)00801741123184
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

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: 09/11/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513041505F
• Device Lot Number: GFBY0869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 64