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	02/13/2017
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.Under magnification, it was observed the balloon had a partial circumferential rupture in the middle of the balloon, approximately 24mm from distal end of the balloon.Under 30x-40x magnification, the balloon was examined and found to have a circumferential rupture, approximately 3.2mm long.No fragments were missing from the balloon or catheter.Functional testing determined the balloon was unable to be fully inflated, due to the material rupture.A lot history review revealed (b)(4) additional 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 partial circumferential rupture in the middle of the balloon.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 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 ruptured circumferentially when treating the target lesion at approximately 12 atmospheres.The health care professional (hcp) used a contralateral approach through a 6 french terumo destination introducer sheath over an advantage guidewire to gain access to the mildly calcified target lesion.The hcp predilated the target lesion with a mustang balloon.The morphology of the vessel pathway was unknown, but no previously placed stents were present.The hcp used negative pressure during advancement of the catheter to the target lesion.Allegedly, after the balloon ruptured, the hcp reportedly was able to retrieve all balloon fragments from the patient.After the lutonix dcb catheter and balloon fragments were allegedly removed, another device was reportedly used to complete the procedure.The lutonix dcb was returned for further evaluation.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: 6381500
• Report Number: 3006513822-2017-00043
• Device Sequence Number: 1056470
• Product Code: ONU
• UDI-Device Identifier: 00801741123269
• UDI-Public: (01)00801741123269(17)180429(10)GFAR3876
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/14/2017

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: 04/29/2018
• Device Model Number: 9004
• Device Catalogue Number: LX351306605F
• Device Lot Number: GFAR3876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 64