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	03/10/2016
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 no visual damage to the catheter.Functional testing of the balloon portion of the catheter was performed which revealed a material rupture in the proximal one-third of the balloon.The complaint sample was decontaminated and prepared for further evaluation.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: the returned sample is undergoing further evaluation which has not yet been completed.Upon completion of the investigation, a supplement report will be submitted with all relevant information.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at 4 atmospheres during the first inflation while treating the target lesion in the left proximal superficial femoral artery(sfa).A contralateral approached was used by the health care professional (hcp) to gain access with a 6 french terumo introducer sheath over an 035 terumo glidewire in the right common femoral artery.The hcp prepared the lutonix dcb normally and removed the balloon protector without issues.The hcp did not apply negative pressure to the balloon during a short advancement to the calcified target lesion.After the lutonix dcb allegedly ruptured, the hcp reportedly removed the lutonix dcb without difficulty through the introducer sheath.The procedure was successfully completed using a 5x40 angiosculpt followed by another lutonix dcb.The lutonix dcb was requested to be returned for further evaluation.There was no reported consequence or impact to the patient.
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter, which revealed no visual damage to the catheter.Functional testing of the balloon portion of the catheter was performed which revealed a material rupture in the proximal one-third of the balloon.The complaint sample was decontaminated and prepared for further evaluation.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 the material rupture to be a longitudinal tear, perpendicular to the length of the balloon, distal to proximal marker band.A definitive root cause for the rupture could not be determined.It is unknown if procedural issues contributed to the reported event.If additional information is obtained, a supplement report will be submitted with all relevant information.
Event or Problem Description
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at 4 atmospheres during the first inflation while treating the target lesion in the left proximal superficial femoral artery(sfa).A contralateral approached was used by the health care professional (hcp) to gain access with a 6 french terumo introducer sheath over an 035 terumo glidewire in the right common femoral artery.The hcp prepared the lutonix dcb normally and removed the balloon protector without issues.The hcp did not apply negative pressure to the balloon during a short advancement to the calcified target lesion.After the lutonix dcb allegedly ruptured, the hcp reportedly removed the lutonix dcb without difficulty through the introducer sheath.The procedure was successfully completed using a 5x40 angiosculpt followed by another lutonix dcb.The lutonix dcb was requested to be returned for further evaluation.There was no reported consequence or impact to the patient.

• 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: 5550841
• Report Number: 3006513822-2016-00077
• Device Sequence Number: 394225
• Product Code: ONU
• UDI-Device Identifier: 00801741088568
• UDI-Public: (01)00801741088568(17)171007(10)GFZJ1376
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 03/10/2016

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: 10/07/2017
• Device Model Number: 9004
• Device Catalogue Number: LX35130640
• Device Lot Number: GFZJ1376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2016
• Supplement Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 75