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

Model Number	9004
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter which revealed the distal end of the balloon was observed to be severely bunched and wrinkled, causing the balloon to bulge and overlap near the distal cone of the balloon.The distal two thirds of the balloon was wrinkled.The inner lumen was bent in the distal cone area of the balloon.Blood residue was present in the inflation lumen and the balloon.The shaft was kinked approximately 81 mm proximal to the proximal bond.Functional testing revealed the guidewire was unable to advance completely through the inner lumen.Furthermore, functional testing was attempted and the catheter was unable to be advanced through the recommended introducer sheath, due to the damage of the balloon¿s distal cone.A lot history review revealed this is the only complaint associated with this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: returned product analysis confirmed the catheter was difficult to retract through the introducer sheath which resulted in a surgical intervention to remove the catheter from the patient¿s vasculature.The returned sample¿s damage was possibly due to excessive force used by the hcp during retraction of the lutonix dcb.There was nothing found to indicate there was a manufacturing related cause for this event.A definitive root cause for the difficulty to retract the catheter through the introducer sheath could not be determined.It is unknown if procedural or patient issues contributed to the reported event.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 target lesion, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly became stuck in the introducer sheath during retraction of the device.The health care professional (hcp) used an ipsilateral approach with a 5f terumo introducer sheath over an 035 terumo guidewire.The hcp treated the target lesion without difficulty.After treatment, the hcp deflated the lutonix dcb completely and verified the deflated balloon under fluoroscopy.Negative pressure was applied to the lutonix dcb and the hcp attempted to retract the device.The balloon portion of the catheter became stuck in the introducer sheath.The hcp reapplied negative pressure several times, but the catheter remained stuck.The hcp surgically intervened to retrieve the balloon from the patient.The original access to the patient was maintained.The lutonix dcb was returned for evaluation.The procedure was completed.No additional 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: 7016835
• Report Number: 3006513822-2017-00287
• Device Sequence Number: 1006091
• Product Code: ONU
• UDI-Device Identifier: 00801741122934
• UDI-Public: (01)00801741122934
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P130024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 9004
• Device Catalogue Number: 9090475700060
• Device Lot Number: GFBQ1407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention