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	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed there are no similar complaints associated with this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: the actual sample was not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.Reportedly, the entire superficial femoral artery (sfa) pathway was heavily calcified, and the hcp did not predilate the target lesion in the popliteal artery.The hcp prepared the lutonix dcb in the normal fashion and successfully applied negative pressure to the balloon prior to inserting the catheter into the patient.Reportedly, the hcp did not apply negative pressure to the balloon while advancing the catheter to the target lesion.In the hcp opinion, the calcification in the sfa was the reason the lutonix dcb ruptured.Based on the instructions for use (ifu), the occurrence of reocclusion is an inherent risk of any pta procedure, and has been reported in clinical trials of drug coated balloons.If additional information becomes known to the manufacturer, a supplemental report will be provided will all relevant information.The information provided by bard 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 bard.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at 6 atmospheres (atms) while treating the target lesion located in the left popliteal artery.The health care professional (hcp) used a contralateral approach to treat the popliteal artery.Reportedly, the entire superficial femoral artery (sfa) pathway was heavily calcified, and the hcp did not predilate the target lesion in the popliteal artery.The hcp prepared the lutonix dcb in the normal fashion and successfully applied negative pressure to the balloon prior to inserting the catheter into the patient.Reportedly, the hcp did not apply negative pressure to the balloon while advancing the catheter to the target lesion.On the first inflation, the hcp allegedly inflated the lutonix dcb to 6 atms.The ruptured lutonix dcb was successfully removed in it's entirety.Reportedly, the rupture was a identified by the hcp to be a pinhole.In the hcp's opinion, the calcification in the sfa was the reason the lutonix dcb ruptured.The hcp reportedly used an additional two lutonix dcb's to successfully complete the patient's procedure.The lutonix dcb was discarded by the user facility and is not available 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: 6972736
• Report Number: 3006513822-2017-00201
• Device Sequence Number: 1227633
• Product Code: ONU
• UDI-Device Identifier: 00801741123245
• UDI-Public: (01)00801741123245
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/24/2017
• Report Date (Section F): 09/28/2017

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: 04/04/2018
• Device Model Number: 9004
• Device Catalogue Number: LX3513051505F
• Device Lot Number: GFAP2158
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 81
• Date Report Sent to FDA: 09/28/2017