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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
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C.R. BARD, INC. (GFO) LUTONIX 035 DRUG COATED BALLOON PTA CATHETER Back to Search Results
Model Number 9004
Device Problems Difficult to Insert (1316); Retraction Problem (1536); Material Rupture (1546)
Patient Problem Injury (2348)
Event Date 01/19/2019
Event Type  Injury  
Manufacturer Narrative
Analysis: the sample was returned from the user facility; however, a device evaluation has not been completed.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: the actual sample was returned for evaluation, but the evaluation has not been completed.The dhr found nothing to indicate a manufacturing related cause for this event.Upon completion of the investigation regarding the evaluation of the sample, 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 allegedly ruptured longitudinally in the middle of the balloon during transit through an introducer sheath to the lesion in the left superficial femoral artery (sfa).The health care professional (hcp) used a contralateral approach to gain patient access.The hcp prepped the target lesion by pre-dilating with an unknown device.Reportedly, the sales rep in the procedure opened a 6fr lutonix dcb.The hcp used a 5x55 cook medical ansel sheath and a terumo glidewire advantage guidewire to deliver the lutonix dcb to the target lesion.The hcp noted that the dcb was tight going into the sheath.The sales rep informed the physician that the wrong balloon had been opened for the 5fr introducer sheath that was being used, but the hcp proceeded with the case.Upon reaching the target lesion in the left sfa, the hcp applied negative pressure with the unknown inflation device and allegedly blood came back into inflation device.The hcp attempted to remove the ruptured balloon through the undersized sheath, but 1-2 cm of the distal balloon would not retract through the sheath.The physician decided to do a femoral cut down to safely remove the sheath and balloon as a single unit.After the device was retrieved, the procedure was aborted.The physician cut through the sheath, which cut the balloon in half, to verify the entire balloon was removed from the patient.The entire balloon was present and intact.The sample was returned for further evaluation.No further adverse events have been reported.
 
Manufacturer Narrative
Analysis/device evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter.The sample was returned with the guidewire stuck in the inner lumen, which was evident from the hub end.The proximal end of balloon was torn and the portion of the balloon was missing.The outer shaft was also separated proximal to proximal balloon area.The inner lumen was broken and separated at around 110mm from the torn proximal balloon.The remaining portion of the inner lumen and shaft was attached to the hub.The entire inner lumen was severely accordioned and the outer shaft intermittently focally necked and overlapped at multiple places.The inner lumen severely accordioned distal to strain relief and outer shaft overlapped up to 125cm from the strain relief.The 5f introducer sheath was returned with severe damage to the coils.The coils were stretched, broken and distorted.A portion of the proximal balloon was stuck inside the coils and damaged.The opposite end of the coil was torn, stretched and filars damaged.Due to the condition of the returned catheter, functional testing could not be performed.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: returned product analysis confirmed the lutonix dcb had a longitudinal rupture in the middle of the balloon.The dhr found nothing to indicate a manufacturing related cause for this event.The ifu states the minimum recommended introducer sheath size for a dcb with a diameter of 6.00mm is 6 french (fr), but the physician used a 5fr introducer sheath.The fact that dcb was tight going through the sheath damaged the shaft and the balloon.During the retraction possibly extra force was applied that caused the sheath to be severely damaged, torn and the filars distorted.A definitive root cause could not be determined based on the information provided.If additional relevant information becomes available, 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 allegedly ruptured longitudinally in the middle of the balloon during transit through an introducer sheath to the lesion in the left superficial femoral artery (sfa).The health care professional (hcp) used a contralateral approach to gain patient access.The hcp prepped the target lesion by pre-dilating with an unknown device.Reportedly, the sales rep in the procedure opened a 6fr lutonix dcb.The hcp used a 5x55 cook medical ansel sheath and a terumo glidewire advantage guidewire to deliver the lutonix dcb to the target lesion.The hcp noted that the dcb was tight going into the sheath.The sales rep informed the physician that the wrong balloon had been opened for the 5fr introducer sheath that was being used, but the hcp proceeded with the case.Upon reaching the target lesion in the left sfa, the hcp applied negative pressure with the unknown inflation device and allegedly blood came back into inflation device.The hcp attempted to remove the ruptured balloon through the undersized sheath, but 1-2 cm of the distal balloon would not retract through the sheath.The physician decided to do a femoral cut down to safely remove the sheath and balloon as a single unit.After the device was retrieved, the procedure was aborted.The physician cut through the sheath, which cut the balloon in half, to verify the entire balloon was removed from the patient.The entire balloon was present and intact.The sample was returned for further evaluation.No further adverse events have been reported.
 
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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 Key8336713
MDR Text Key136065358
Report Number3006513822-2019-00020
Device Sequence Number1
Product Code ONU
UDI-Device Identifier00801741178733
UDI-Public(01)00801741178733
Combination Product (y/n)N
PMA/PMN Number
P130024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 03/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/27/2019
Device Model Number9004
Device Catalogue NumberLX351306220
Device Lot NumberGFCV3880
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2019
Event Location Hospital
Date Manufacturer Received03/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age62 YR
Patient Weight118
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