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

Model Number 9004

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis: the sample is being returned to the manufacturer at this time; therefore, evaluation is anticipated but has not yet begun.A lot history review revealed this is the only complaint for corporate lot number gfcr3705.A reviewed of the manufacturing record showed the lot was manufactured to specification.Conclusion: the actual sample has not been received, but its return is anticipated.The device history record (dhr) found nothing to indicate a manufacturing related cause for this event.Upon completion of the investigation, a supplement report will be submitted with all relevant information.

Event Description

It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was difficult to deflate after treatment of the target lesion in the proximal superficial femoral artery (sfa).The health care professional (hcp) used a different manufacturer's dcb to treat the other areas of the target vessel.The lutonix dcb was inflated successfully, but then failed to deflate and rewrap properly.The lutonix dcb would not move over the guidewire and thus the catheter became stuck.The hcp successfully used a double wire technique to remove the catheter.Reportedly, this technique leads to the entire sheath, guidewire, and catheter to be removed simultaneous from the patient.After successful removal of the lutonix dcb from the patient, the hcp attempted to inflate the lutonix dcb balloon, but it would not fully inflate.Reportedly, post removal inflation was able to reach 5 atmospheres without the presence of a leak.The lutonix dcb was requested to be returned for evaluation.No adverse patient outcomes were reported.

Event Description

It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was difficult to deflate after treatment of the target lesion in the proximal superficial femoral artery (sfa).The health care professional (hcp) used a different manufacturer's dcb to treat the other areas of the target vessel.The lutonix dcb was inflated successfully, but then failed to deflate and rewrap properly.The lutonix dcb would not move over the guidewire and thus the catheter became stuck.The hcp successfully used a double wire technique to remove the catheter.Reportedly, this technique leads to the entire sheath, guidewire, and catheter to be removed simultaneous from the patient.After successful removal of the lutonix dcb from the patient, the hcp attempted to inflate the lutonix dcb balloon, but it would not fully inflate.Reportedly, post removal inflation was able to reach 5 atmospheres without the presence of a leak.The lutonix dcb was requested to be returned for evaluation.No adverse patient outcomes were reported.

Manufacturer Narrative

H3 analysis: device evaluation: the sample analysis confirmed device was severely damaged with the inner lumen accordioned blocking the inflation lumen, which would cause deflation issues.Subsequently, difficulty removing the catheter, due to not fully deflating the balloon, resulted in the catheter shaft detachment, distal tip of the catheter being pulled inside the balloon, tearing of the inner lumen, and the balloon overlapping itself.The returned introducer sheath was severely damaged with the outer layer and inner filar separating from the inner layer of the sheath.The returned guidewire filar is uncoiled with severe damage consisting of kinks and prominent curves.Due to the extensive damage to the lutonix dcb, introducer sheath, and guidewire through the use of excessive force by the user and all products were removed as a single unit.The physician noted no adverse patient outcomes were reported.A lot history review revealed this is the only complaint for corporate lot number gfcr3705.A reviewed of the manufacturing record showed the lot was manufactured to specification.Conclusion: the returned sample analysis confirmed the reported issues with the catheter as a result of excessive force by the user and all products were removed as a single unit.The physician noted no adverse patient outcomes were reported.The device history record (dhr) found nothing to indicate a manufacturing related cause for this event.If additional information becomes available, a supplement report will be submitted with all relevant information.

• 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
• MDR Report Key: 8676830
• MDR Text Key: 147753894
• Report Number: 3006513822-2019-00094
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741166860
• UDI-Public: (01)00801741166860
• Combination Product (y/n): N
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 9004
• Device Catalogue Number: 9090413500100
• Device Lot Number: GFCR3705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/06/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR