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

Model Number 9004

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

Analysis: the samples were discarded at the user facility; therefore, evaluations of the actual samples are unable to be performed.The product identifiers were unable to be obtained; therefore, a lot history review and device history record (dhr) were unable to be performed.Multiple attempts have been made to obtain the lot number.The facility did not have the patient age available at the time of this report.Conclusion: the actual samples were not received for evaluation.If additional information is received, a supplement 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.(b)(4).

Event Description

It was reported that after effective treatment with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, the health care professional (hcp) allegedly was unable to retract the lutonix dcb through a 5 fr arrow introducer sheath.The hcp gained patient access through the right common femoral artery, which was a contralateral approach to the target lesion in the left superficial femoral artery (sfa).The hcp predilated the 140 mm target lesion in the left sfa successfully.The lutonix dcb was prepared in the normal fashion, while removing the balloon protector without issues.The vessel and tracking path morphology was not reported to be calcified or tortuous in nature.After successful treatment of the lesion, the hcp attempted to retract the lutonix dcb, but it was unable to be removed through the introducer sheath.The hcp exchanged the 0.035 guidewire for a 0.014 guidewire to maintain patient access and removed the introducer sheath and the lutonix dcb catheter together.Once removed, the hcp placed a new sheath over the 0.014 guidewire and patient treatment was completed.The sample was discarded by the user facility.No adverse patient effects were reported.

• 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): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: mike gaffney ; 9409 science center dr; new hope, MN 55428 ; 7634458639
• MDR Report Key: 5237419
• MDR Text Key: 31656118
• Report Number: 3006513822-2015-00060
• Device Sequence Number: 1
• Product Code: ONU
• 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: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9004
• Device Catalogue Number: LX351305150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 52