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

Model Number 9004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle Spasm(s) (1966)

Event Date 06/17/2016

Event Type  Injury  

Manufacturer Narrative

The sample was not returned to the user facility; therefore, device evaluation is unable to be performed.A lot history review revealed there are no similar complaints 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.Based on the instructions for use (ifu), the occurrence of a vessel spasm is an inherent risk of any pta procedure, and has been reported in clinical trials of drug coated balloons.If additional information becomes known to the manufacturer, a supplemental report will be provided will all relevant information.

Event Description

It was reported a vessel spasm allegedly occurred after treatment with the second lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter.The health care professional (hcp) gained access to treat the non-calcified right distal superficial femoral artery (sfa).The hcp performed an atherectomy and predilated the target lesion with a scoring percutaneous transluminal angioplasty (pta) balloon.Upon completing the treatment with the second lutonix dcb, the vessel allegedly experienced an acute vessel recoil and closure.The hcp deployed a supra stent to successfully complete the procedure.The lutonix dcb was discarded by the user facility and are not available for return.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: 5820948
• MDR Text Key: 50387914
• Report Number: 3006513822-2016-00147
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741088674
• UDI-Public: (01)00801741088674(17)160925(10)GFYI3436
• 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: health professional,other,stu
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2016
• Device Model Number: 9004
• Device Catalogue Number: LX351305100
• Device Lot Number: GFYI3436
• 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
• Date Device Manufactured: 10/28/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 73