MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATHETER

Model Number	9004
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter.It was revealed the proximal end of the balloon was wrinkled with kinks on the shaft.The distal end of the balloon surrounding the bond was torn with the balloon shifted over the tip and damaged.The shaft was kinked proximal to the balloon in the area of the hcp holding the shaft to insert the balloon.Functional testing revealed the guidewire could not be inserted due to the outer lumen damaged causing constriction to inner lumen and the balloon damaged.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.Conclusion: returned product analysis confirms the reported event of unable to deflate balloon due to damage to the distal and proximal ends of the balloon and shaft and the balloon shifted at distal end.However, the evaluation could not identify the cause of why the balloon and shaft was damaged and shifted.The health care provider indicated there were no issues with preparation of the device.It is unknown if the patients vasculature or anatomy was challenging.Because the device was not returned for evaluation, a definite root cause for the reported event could not be determined.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 after treating the superficial femoral artery with an lutonix percutaneous transluminal drug coated angioplasty balloon, the balloon allegedly could not be deflated from eight atmospheres after several attempts when using an indeflator.The health care professional allegedly utilized a needle to puncture the balloon through the skin.After the balloon was deflated, the catheter could be removed without difficulties.The health care provider indicated the patient's status was good post procedure.
Additional Manufacturer Narrative
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.

• 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: 5511308
• Report Number: 3006513822-2016-00063
• Device Sequence Number: 13576779
• Product Code: ONU
• UDI-Device Identifier: 00801741088728
• UDI-Public: (01)00801741088728(17)160430(10)GFYD3101
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 9004
• Device Catalogue Number: 9020413600120
• Device Lot Number: GFYD3101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2015
• 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: 03/18/2016
• Supplement Report FDA Received Date: 04/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention