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

Model Number	9004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolus (1830)
Date of Event	01/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was discarded at the user facility; therefore, evaluation was unable to be performed.The lot history reviews revealed these two complaints were associated with the same patient and are the only complaints for this lot.A review of the device history record (dhr) shows the lot was manufactured to specification.Conclusion: the actual sample will not be received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.Based on the instructions for use (ifu), the occurrence of a embolization is an inherent risk of any pta procedure.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, after treatment with two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, allegedly an embolization occurred at distal end of the target lesion.The target lesion and vessel morphology revealed 80-90% segmental occlusion with two distinct areas which were most significant.The health care professional (hcp) gained access to the left femoral artery and performed an arthrectomy proceeded by predilation with a scoring pta catheter.The hcp treated the target lesion with two lutonix dcb's.During the procedure post dcb treatment, the hcp reviewed the angiography, which revealed a good result within the target lesion.However, there was almost no flow to the distal vessels suggesting an embolization.The hcp proceeded to treat the embolization by removing the filter filled with thrombogenic material and using angiojet thrombectomy with multiple passes with a 4 and 5 french sizes.After treatment, angiography revealed there was a focal occlusion distal to the target lesion.Additional ballooning attempts were performed by the hcp, which increased flow distally, but the resistant clot still remained.The patient was placed on a regiment of tissue plasminogen activator (tpa).Later that evening, the patient was brought back to the lab for additional thrombectomy with normal pta, which successfully restored blood flow below the target lesion.The sample was discarded by the user facility and will not be returned for evaluation; however, diagnostic images were obtained for review.The patient was discharged, with no additional adverse patient effects reported.This is one of two products involved with the reported event and are associated manufacturers report numbers 3006513822-2016-00010.

• 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: 5457568
• Report Number: 3006513822-2016-00011
• Device Sequence Number: 13514583
• Product Code: ONU
• UDI-Device Identifier: 00801741105029
• UDI-Public: (01)00801741105029(17)170707(10)GFZH0473
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2017
• Device Model Number: 9004
• Device Catalogue Number: BSCLX351306150
• Device Lot Number: GFZH0473
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2016
• 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: Hospitalization
• Patient Age: 88 YR
• Patient Weight: 84