MAUDE Adverse Event Report: 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	Intimal Dissection (1333)
Date of Event	11/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed.A lot history review revealed there is no other dissection complaints associated with this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: the actual samples were not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.The investigator assessed the event was not related to the study devices or procedure.Based on the instructions for use (ifu), the occurrence of dissection is an inherent risk of any pta procedure.If additional information becomes known to the manufacturer, a supplemental report will be provided with 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 through a clinical registry that during the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the left mid superficial femoral artery (sfa).During the index procedure, the patient's left sfa was observed to have a grade b, non-flow limiting, dissection after pre-dilation.The heath care professional (hcp) proceeded to treat the diseased vessel with the two lutonix dcbs.It was observed that the patient had a grade c, flow-limiting, dissection after treatment with the lutonix devices.The hcp chose to use the pre-dilation device, bard rival balloon, to do a post-dilation to resolve the dissection.The hcp deemed the procedure to be successful.The investigator assessed that the event was not related to the study devices or procedure.The samples were discarded by the user facility and are not available for further evaluation.No adverse patient effects were reported.This is one of two products involved with the reported event and the associated manufacturer¿s report number is 3006513822-2018-00191.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Common Device Name: DRUG COATED BALLOON PTA CATHETER
• MDR Report Key: 7864140
• Report Number: 3006513822-2018-00192
• Device Sequence Number: 1835615
• Product Code: ONU
• UDI-Device Identifier: 00801741088667
• UDI-Public: (01)00801741088667
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2018

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: 04/30/2017
• Device Model Number: 9004
• Device Catalogue Number: 9050613400100
• Device Lot Number: GFZE3153
• 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: 09/11/2018
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 70