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	10/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter which revealed the balloon was ruptured longitudinally, perpendicular to the length of the balloon from the proximal balloon bond to the distal balloon bond.The inner lumen was exposed due to the rupture.The inner lumen has a severe kink at the proximal third of the balloon area.Functional testing was unable to be performed due to the condition of the returned catheter.A lot history review revealed this is the only complaint associated with balloon rupture for this lot.A device history record (dhr) review was performed and noted the device was manufactured to specification prior to being released for distribution.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: returned product analysis confirmed a longitudinal material rupture from the proximal balloon bond to distal balloon bond.Additional damage was present, a severe inner shaft kink in the proximal third of the balloon area, which may be the result of the packaging technique used to return the device to the manufacturer.Based on the reported information, the balloon was inflated to 3 atmospheres.A definitive root cause could not be determined due to the sample returning with a bond to bond longitudinal rupture which most likely occurs when inflated greater than rated burst pressure(rbp).Due to the target lesion being heavily calcified, the hcp's opinion is the calcification contributed to the material rupture of the balloon during treatment.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at three atmospheres (atm) during the first inflation.The health care professional (hcp) used a brachial approach to treat the common femoral artery(cfa).The hcp applied negative pressure during advancement to the target lesion.The target lesion was heavily calcified.In the hcp's opinion, the heavily calcified lesion contributed to the rupturing of the balloon at three atms during lesion treatment.The lutonix dcb was removed successfully, and reportedly, another drug coated balloon pta catheter was used to complete the procedure.The lutonix dcb was returned for further evaluation.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: 6075589
• Report Number: 3006513822-2016-00195
• Device Sequence Number: 569077
• Product Code: ONU
• UDI-Device Identifier: 00801741123283
• UDI-Public: (01)00801741123283(17)180429(10)GFAR3527
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2016

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: 04/29/2018
• Device Model Number: 9004
• Device Catalogue Number: LX3513061005F
• Device Lot Number: GFAR3527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Event Location: Outpatient Treatment Facility
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 78