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

Model Number	9004
Medical Device Problem Codes	Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis: the sample was discarded at the user facility; therefore, an evaluation is unable to be performed.A lot history review revealed this is the only complaint associated with torn material 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: the actual sample was not received for evaluation.Although requested, the patient demographics were unavailable.The hcp removed the introducer sheath and the broken off balloon portion was lodged in the distal tip of the introducer sheath.Once the introducer sheath was removed, the balloon portion was also removed from the patient.It is unknown, if the lutonix dcb was confirmed to be deflated under fluoroscopy or if negative pressure was applied prior to retraction.The hcp performed a straight shot fluoroscopy which revealed no remaining balloon/foreign body in the patient.The procedure was completed with a 4 french cook micropuncture catheter to ensure there was no damage to the arterial vasculature.If additional information is obtained from the field, 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.
Event or Problem Description
It was reported, after off-label treatment of the target lesion during retraction, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly broke off at the distal tip of the introducer sheath in the right external iliac artery.The health care professional (hcp) was treating a target lesion in the tortuous left common femoral artery with a lutonix 5 mm x 150 mm dcb.The hcp used a cook 5 french flexor check-flo introducer sheath over a guidewire (brand unknown) to gain patient access.After a successful inflation and deflation of the lutonix dcb, the hcp started to retract the catheter.The catheter broke off at the distal end of the introducer sheath.It is unknown, if the lutonix dcb was confirmed to be deflated under fluoroscopy or if negative pressure was applied prior to retraction.Then, the hcp attempted to reinsert the guidewire into the inner lumen of the broken off portion of the balloon.This attempt was unsuccessful.The hcp removed the introducer sheath and the broken off balloon portion was lodged in the distal tip of the introducer sheath.Once the introducer sheath was removed, the balloon portion was also removed from the patient.The hcp performed a straight shot fluoroscopy, which revealed no remaining balloon/foreign body in the patient.The procedure was completed with a 4 french cook micropuncture catheter to ensure there was no damage to the arterial vasculature.Although requested, the patient demographics were unavailable.The lutonix dcb was discarded by the user facility and is not available for evaluation.No adverse patient outcomes 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: 7837522
• Report Number: 3006513822-2018-00189
• Device Sequence Number: 19154283
• Product Code: ONU
• UDI-Device Identifier: 00801741123245
• UDI-Public: (01)00801741123245
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2018

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: 09/22/2018
• Device Model Number: 9004
• Device Catalogue Number: LX3513051505F
• Device Lot Number: GFAW2811
• 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: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1