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

Model Number	9004
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2018
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 which revealed heavy blood residue in multiple places and the balloon portion of the catheter was partially inflated.Functional testing was attempted by first inserting a guidewire, but the heavy blood residue impeded the guidewire from advancing completely through the inner lumen.A solution was used in an attempt to inflate the balloon, but the heavy blood residue in the inflation lumen made this testing unsuccessful.The balloon was viewed under 30x magnification, which revealed a longitudinal material rupture originating from the middle of the balloon to the distal area of the balloon, under a fold.A lot history review revealed this is the only complaint associated with balloon rupture for this lot.A device history record (dhr) review was performed and noted the device was manufactured to specification prior to being released for distribution.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: returned product analysis confirmed a longitudinal material rupture originating from the middle of the balloon to the distal area of the balloon, under a balloon fold.There was nothing found to indicate there was a manufacturing related cause for this event.The hcp noted calcification was present in the target vessel.Allegedly, the hcp advanced the device under negative pressure to the intended treatment location.A definitive root cause for the rupture could not be determined.It is unknown if procedural issues contributed to the reported event.
Event or Problem Description
It was reported that one of three lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters allegedly was unable to be inflated after being advanced to the target lesion in the left proximal superficial femoral artery (sfa).The health care professional (hcp) used a contralateral approach to gain patient access.The hcp noted some vessel calcification.Reportedly, no stents were present in the vessel pathway or in the target lesion.The hcp prepared the first lutonix dcb and treated the target location without issues and deemed the first treatment successful.The hcp used a second lutonix dcb to treat the target lesion, further.Reportedly, the hcp prepared the second lutonix dcb and advanced the balloon under negative pressure to the target lesion.Allegedly, while the hcp was inflating the balloon, the desired pressure was never achieved.Reportedly, the second lutonix dcb would not inflate.The hcp removed the second lutonix dcb and treated the target lesion with one additional lutonix dcb, which was successful without issues.The second lutonix dcb was returned for evaluation.No adverse patient outcomes were reported.

• 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: 8054070
• Report Number: 3006513822-2018-00254
• Device Sequence Number: 16564941
• Product Code: ONU
• UDI-Device Identifier: 00801741123306
• UDI-Public: (01)00801741123306
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2018

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: 12/01/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513061505F
• Device Lot Number: GFBY3509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 76