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	01/08/2016
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 several kinks along the length of the catheter.The catheter appears to have been reshaped during the return shipping process.Functional testing of the balloon portion of the catheter was performed by attempting to inflate the balloon.The balloon did not inflate and fluid began dripping from the distal end of the balloon.A material rupture was identified near the distal marker band.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 additional evaluation which has not yet been completed.Upon completion of the investigation, a supplement report will be submitted 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 that during off label treatment of in-stent restenosis on the brachiocephalic vein a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at 10 atmospheres with the first inflation.The health care professional (hcp) gained patient access with a 7 french introducer sheath and terumo glidewire.The hcp prepared and flushed the lutonix dcb in the normal fashion and used a bard presto indeflator to inflate the lutonix dcb.After the lutonix dcb ruptured, it was removed without difficulty, and another lutonix dcb was used to successfully treat the target vessel.The physician was in-serviced by bard pre procedure regarding the off label use of lutonix dcb catheters, but still elected to use the catheter for the patient procedure.Bard performed an additional in-service post procedure regarding the off label use and proper use of lutonix dcb's.No adverse patient effects were reported.
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter, which revealed several kinks along the length of the catheter.The catheter appears to have been reshaped during the return shipping process.Functional testing of the balloon portion of the catheter was performed by attempting to inflate the balloon.The balloon did not inflate and fluid began dripping from the distal end of the balloon.A material rupture was identified near the distal marker band.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 in the balloon, starting at the distal bond.The catheter shaft was kinked in multiple locations and severely bent at the proximal end of the proximal balloon bond which caused extreme constriction of the inner lumen.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.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 that during off label treatment of in-stent restenosis on the brachiocephalic vein a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at 10 atmospheres with the first inflation.The health care professional (hcp) gained patient access with a 7 french introducer sheath and terumo glidewire.The hcp prepared and flushed the lutonix dcb in the normal fashion and used a bard presto indeflator to inflate the lutonix dcb.After the lutonix dcb ruptured, it was removed without difficulty, and another lutonix dcb was used to successfully treat the target vessel.The physician was in-serviced by bard pre procedure regarding the off label use of lutonix dcb catheters, but still elected to use the catheter for the patient procedure.Bard performed an additional in-service post procedure regarding the off label use and proper use of lutonix dcb's.No adverse patient effects were reported.

• 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: 5404735
• Report Number: 3006513822-2016-00003
• Device Sequence Number: 223520
• Product Code: ONU
• UDI-Device Identifier: 00801741088568
• UDI-Public: (01)00801741088568(17)170716(10)GFZG1973
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Followup
• Report Date (Section B): 01/08/2016

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: 07/16/2017
• Device Model Number: 9004
• Device Catalogue Number: LX35130640
• Device Lot Number: GFZG1973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• 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: 02/02/2016
• 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: 61 YR
• Patient Weight: 71