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

Model Number	9004
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
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 this is the only material rupture complaint associated with this lot.A review of the device history record (dhr) indicated the lot was manufactured to specification prior to the distribution of the product.Conclusion: the actual sample was not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.The hcp predilated the target lesion and prepared the lutonix dcb based on the recommendations established in the ifu.The lutonix dcb was used to successfully treat the target lesion, but was inflated for a second time when the material rupture occurred.A definitive root cause could not be determined based on the information provided.It is unknown if the patient and/or procedural issues contributed to the reported event.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at 10 atmospheres after the second inflation, during the treatment of the target lesion in the superficial femoral artery (sfa).The health care professional (hcp) gained patient access through the left common femoral artery with a 5 french cook ansel introducer sheath over an 018 guidewire (brand unknown).The hcp predilated the target lesion and prepared the lutonix dcb based on the recommendations established in the ifu.After the second inflation when the material rupture occurred, the hcp noted the lutonix dcb was difficult to retract through the introducer sheath.Reportedly, the hcp successfully removed the entire lutonix dcb.The hcp used another balloon to successfully complete the 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 PTA BALLOON CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 8055719
• Report Number: 3006513822-2018-00257
• Device Sequence Number: 16475550
• Product Code: ONU
• UDI-Device Identifier: 00801741163425
• UDI-Public: (01)00801741163425
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 11/09/2018

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: 06/01/2019
• Device Model Number: 9004
• Device Catalogue Number: LX3513062205F
• Device Lot Number: GFCS3765
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/09/2018
• 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