MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG CAOTED 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	05/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/preliminary evaluation: upon receipt of the sample, visual examination of the entire length of the catheter revealed several kinks in the catheter's shaft and in the balloon.Functional testing was performed which revealed the balloon inflated, but the inflation solution continued to flow from the distal tip of the catheter.The exact source of the material rupture could not be determined without a microscope inspection.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.Conclusion: the returned sample is undergoing evaluation which has not yet been completed.Additional requests for the patient age and weight have been requested from the complainant, but the complainant states, "additional information is unknown." 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 a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly would not maintain pressure while treating the target lesion.The health care professional (hcp) prepared the target lesion in the proximal popliteal artery with a jetstream atherectomy device.The hcp prepared the lutonix dcb in the normal fashion and removed the balloon protector without issues.The lutonix dcb was advanced under negative pressure to the target lesion.The hcp incrementally inflated the balloon to 4 atmospheres, but the balloon was allegedly not maintaining pressure.The hcp manually continued to keep pressure in the balloon for two minutes.The hcp felt the treatment was successful.The lutonix dcb was removed and the procedure was completed after another lutonix dcb was used to treat a second lesion in the superficial femoral artery (sfa).The lutonix dcb was returned for further evaluation.No adverse patient effects were reported.
Additional Manufacturer Narrative
(b)(4).Analysis/device evaluation: upon receipt of the sample, visual examination of the entire length of the catheter revealed several kinks in the catheter's shaft and in the balloon.Functional testing was performed which revealed the balloon inflated, but the inflation solution continued to flow from the distal tip of the catheter.Microscopic inspection was performed at 20x, which revealed inner lumen damage on the outer surface of the inner shaft resulting in solution flowing from the inflation lumen to the inner lumen which drips from the distal tip of the catheter.Destructive analysis confirmed the damage was a perforation of the inner shaft.A lot history review revealed this is the only complaint associated with balloon rupture for this lot.A dhr review was performed and noted the device was manufactured to specification prior to being released for distribution.Based on the information provided, the definitive root cause for the inner lumen damage is manufacturer related.The damage to the inner shaft of the catheter appears to be an isolated incident.Conclusion: the returned sample evaluation which revealed a manufacturer related inner shaft perforation.The damage to the inner shaft of the catheter appears to be an isolated incident.If additional information becomes known to the manufacturer, a supplemental report will be submitted.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 a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly would not maintain pressure while treating the target lesion.The health care professional (hcp) prepared the target lesion in the proximal popliteal artery with a jetstream atherectomy device.The hcp prepared the lutonix dcb in the normal fashion and removed the balloon protector without issues.The lutonix dcb was advanced under negative pressure to the target lesion.The hcp incrementally inflated the balloon to 4 atmospheres, but the balloon allegedly would not maintain pressure.The hcp manually kept pressure in the balloon for two minutes.The hcp felt the treatment was successful.The lutonix dcb was removed and the procedure was completed after another lutonix dcb was used to treat a second lesion in the superficial femoral artery (sfa).The lutonix dcb was returned for further evaluation.No adverse patient effects were reported.

• Brand Name: LUTONIX 035 DRUG CAOTED BALLOON PTA CATHETER
• Common Device Name: DRUG CAOTED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 5784093
• Report Number: 3006513822-2016-00139
• Device Sequence Number: 16372611
• Product Code: ONU
• UDI-Device Identifier: 00801741098451
• UDI-Public: (01)00801741098451(17)170416(10)GFZE1281
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2016

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: 04/16/2017
• Device Model Number: 9004
• Device Catalogue Number: BSCLX35130560
• Device Lot Number: GFZE1281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• 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: 07/11/2016
• Supplement Report FDA Received Date: 08/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1