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

Model Number 9004

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis: the sample was not returned to the user facility; therefore, evaluation of the actual sample is unable to be performed.A lot history review revealed this is the only complaint associated with this lot.A review of the device history record (dhr) shows 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.If additional information is obtained, a supplemental report will be submitted with all relevant information.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 Description

It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly was torn while advancing the catheter to the proximal portion of the mid- distal superficial femoral artery (sfa).The health care professional (hcp) predilated a heavy calcified target lesion which was 300 mm in length with multiple inflations.The first lutonix dcb was advanced through a non tortuous pathway to the distal portion of the target lesion and treatment was successful.Reportedly, the second lutonix dcb was being advanced to the proximal portion of the target lesion, the hcp noted blood entering the indeflator which may indicate a material rupture in the balloon.The hcp never inflated the second lutonix dcb and it was removed successfully without retraction difficulties through the sheath.The procedure was completed with another drug coated balloon.Post-operative imaging was conducted from the lesion down to the foot, reportedly no indication of foreign material was present.The second lutonix dcb was discarded by the user facility and is not available for further evaluation.There was no reported impact or consequence to the patient.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: DRUG COATED BALLOON PTA CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer (Section G): LUTONIX, INC; 9409 science center dr; new hope MN 55428
• Manufacturer Contact: mike gaffney ; 9409 science center dr; new hope, MN 55428 ; 7634458639
• MDR Report Key: 5793714
• MDR Text Key: 49511285
• Report Number: 3006513822-2016-00143
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088759
• UDI-Public: (01)00801741088759(17)180325(10)LUAQ0078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2018
• Device Model Number: 9004
• Device Catalogue Number: LX351305150
• Device Lot Number: LUAQ0078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Weight: 45