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	02/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis: 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 a similar complaint for this lot.A device history record (dhr) was reviewed for this device.A review of the manufacturing record show the lot was manufactured to specification.Conclusion: the actual sample was not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.Since the sample was not received for evaluation the investigation was based on the information received from the field.The physician believes the material rupture is a pinhole and is related to calcification at the distal end of the target lesion.Operational context likely caused or contributed to the material rupture of the balloon.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 experienced a material rupture while treating the target lesion during a (b)(4) study.The health care professional (hcp) reportedly inflated the lutonix dcb within the lifestent to 8 atmospheres to treat calcification in the target lesion.After the treatment was completed, the balloon allegedly ruptured.After successful removal of the catheter, the physician noted the material rupture appeared to be a pinhole, and believes the rupture was related to the patient's pre-existing calcified lesion.Please note that this device is marketed in the united states (us); however, the us instructions for use (ifu) states this device is indicated to be used in de novo lesions up to 15.0 cm in length.This event is being reported only as a malfunction because of the similar device requirement in 21cfr803.50, which is limited to malfunctions.The lutonix dcb was discarded by the user facility.No subsequent 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: 5574846
• Report Number: 3006513822-2016-00091
• Device Sequence Number: 16211166
• Product Code: ONU
• UDI-Device Identifier: 00801741088483
• UDI-Public: (01)00801741088483(17)170930(10)GFZH2227
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2016

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: 09/30/2017
• Device Model Number: 9004
• Device Catalogue Number: 9020410600150
• Device Lot Number: GFZH2227
• 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: 04/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 89