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); Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis/preliminary evaluation: upon receipt of the sample, visual examination of the entire length of the catheter revealed the catheter was returned in four separate pieces, with the introducer sheath still on the catheter shaft.The catheter's inner lumen was detached from the hub and pulled back to the 37 cm geomarker, and stretched from the 73 cm geomarker to the 68 cm geomarker.The catheter inner lumen also showed necking from the 53 cm geomarker to the remainder of the catheter.A lot history review revealed this is the only complaint associated with retraction difficulty resulting in 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.Conclusion: the returned sample is undergoing evaluation which has not yet been completed.Upon completion of the investigation, 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 successful treatment of the non calcified target lesion in the superficial femoral artery (sfa), the lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly was unable to be removed through the 5 french cook ansel introducer sheath.The health care professional (hcp) used a contralateral approach to gain patient access with 5 french cook ansel introducer sheath.Reportedly, after treating the target lesion, the hcp completely deflated the lutonix dcb and verified the completely deflated balloon under fluoroscopy.The hcp still was unable to retract the lutonix dcb through the introducer sheath.Reportedly, the hcp removed the lutonix dcb and the introducer sheath simultaneously.It is unknown if negative pressure was continually applied during the retraction attempt.During the retraction attempt, the lutonix dcb separated into multiple pieces.The entire catheter was removed from the patient without additional surgical intervention.The lutonix dcb was returned 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: 7544571
• Report Number: 3006513822-2018-00129
• Device Sequence Number: 16194295
• Product Code: ONU
• UDI-Device Identifier: 00801741126888
• UDI-Public: (01)00801741126888
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

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: 08/10/2020
• Device Model Number: 9004
• Device Catalogue Number: LX351306805F
• Device Lot Number: GFBV1067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1