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

Model Number	9004
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination of the entire length of the catheter did not reveal any noticeable damage.Functional testing revealed negative pressure could not be maintained.The catheter¿s balloon was attempted to be inflated, but the attempt was unsuccessful due to a material rupture which was identified in the distal end of the balloon.Under magnification, the balloon was examined to characterize the material rupture, which has a crescent shape appearance facing towards the distal tip of the catheter.The catheter tip was also damaged, in a similar crescent shape, facing towards the catheter's balloon which is the opposite of the material rupture.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 have a crescent shape appearance facing towards the distal tip of the catheter.The catheter tip was also damaged, in a similar crescent shape facing towards the catheter's balloon which is the opposite of the material rupture.The balloon appears to be fully intact.There was nothing found to indicate there was a manufacturing related cause for this event.A definitive root cause for the rupture could not be determined.It is unknown if procedural issues or patient anatomy contributed to the reported event.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 was unable to inflate once delivered to the target lesion.The health care professional (hcp) used an ipsilateral approach to treat the distal superficial femoral artery (sfa) and proximal popliteal artery.The vessel was not tortuous in nature.The hcp prepared the lutonix dcb and removed the balloon protector without issues.Reportedly, negative pressure was not applied during preparation and there was no damage to the catheter.Since the balloon did not inflate, the hcp removed the balloon without issues.The procedure was completed with another device.Reportedly, the hcp visually inspected the balloon afterwards and noted "a small lesion at the balloon".The lutonix dcb was requested to be returned for evaluation.No adverse patient outcomes 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: 6775730
• Report Number: 3006513822-2017-00153
• Device Sequence Number: 13646214
• Product Code: ONU
• UDI-Device Identifier: 00801741123139
• UDI-Public: (01)00801741123139
• Combination Product (Y/N): N
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/08/2017

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: 08/30/2019
• Device Model Number: 9004
• Device Catalogue Number: 9090413400040
• Device Lot Number: GFAV2508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1