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	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the sample was returned from the user facility; therefore, device evaluations was performed.Lot history review revealed this is the only complaint for corporate lot number gfdr0558.The dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned from the user facility; therefore, device evaluations was performed.The evaluation confirmed the lutonix dcb allegedly ruptured at 8 atmospheres (atms) on the first inflation while treating the target lesion.It was reported, the hcp prepared the target lesion with a csi shockwave atherectomy device.Upon the first inflation to 8 atm, the balloon allegedly ruptured.The lutonix dcb was removed without difficulties.The returned sample analysis revealed a longitudinal material rupture extending less than a 1 mm in length along the length of the balloon, approximately 132 mm form the distal marker band.The catheter was kinked in multiple locations and the distal tip was damaged.Therefore, the returned sample analysis is consistent with a lutonix dcb being used in a calcified lesion.The root cause of the material rupture could not be determined based upon the available information received from field communications and the returned sample analysis.Label review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that during an angioplasty procedure, a drug coated balloon (lutonix) allegedly ruptured during first inflation.Reportedly, the balloon was removed without any issue.No other information was provided.There was no reported patient injury.

• 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: 8898945
• Report Number: 3006513822-2019-00107
• Device Sequence Number: 19208489
• Product Code: ONU
• UDI-Device Identifier: 00801741163425
• UDI-Public: (01)00801741163425
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 08/15/2019

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: 11/21/2020
• Device Model Number: 9004
• Device Catalogue Number: LX3513062205F
• Device Lot Number: GFDR0558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1