MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONX 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	08/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was discarded at the user facility; therefore, evaluation was unable to be performed.A lot history review revealed this is the only complaint associated with 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: the actual sample was not received for evaluation.A review of the manufacturing record show the lot was manufactured to specification.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 becomes available, 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 would not inflate after the balloon was advanced to the target lesion.The health care professional (hcp) performed a successful predilation of the target lesion.The hcp prepared the lutonix dcb in the normal fashion and removed the balloon protector without issue.The hcp advanced the balloon under negative pressure through a non calcified or tortuous pathway to the target location.After the balloon was removed in its entirety, the hcp noted there was a pinhole in the middle of the balloon.The lutonix dcb was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.

• Brand Name: LUTONX 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: 5948046
• Report Number: 3006513822-2016-00179
• Device Sequence Number: 915618
• Product Code: ONU
• UDI-Device Identifier: 00801741088025
• UDI-Public: (01)00801741088025(17)160710(10)GFYG1027
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2016

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: 07/10/2016
• Device Model Number: 9004
• Device Catalogue Number: LX3575460
• Device Lot Number: GFYG1027
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 73