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

Model Number 9004

Device Problems Difficult to Remove (1528); Torn Material (3024)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

Analysis: the sample is being returned to the manufacturer at this time; therefore, an evaluation is anticipated but has not yet begun.A lot history review revealed this is the only complaint associated with 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 actual sample has not been received, but is anticipated to be returned for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.The hcp reportedly assessed the patient's vasculature angiographically to determine if any vasculature damage occurred.Although requested, additional information regarding the results of the angiographic assessment has not yet been received.Furthermore, allegedly, a piece of the lutonix dcb is missing and medical or surgical intervention may have been performed to prevent permanent impairment.Upon completion of the investigation regarding the angiographic assessment and alleged missing balloon piece, 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 Description

It was reported after a successful treatment, the lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter's balloon allegedly tore during retraction.The health care professional (hcp) used an ipsilateral approach with a 5 french introducer sheath to gain access to the left popliteal artery.The hcp successfully advanced a predilatation balloon through the vessels stented pathway to the calcified target lesion.The target lesion was predilated.Reportedly, the lutonix dcb was advanced to the target lesion successfully and inflated to successfully treat the target lesion.After the treatment, the hcp retracted the lutonix dcb through the stented vessel pathway to the distal tip of the introducer sheath.It is unknown if balloon deflation was confirmed under fluoroscopy or if negative pressure was established prior to the attempted removal of the catheter by the hcp.Reportedly, the hcp was unable to remove the lutonix dcb through the 5 french introducer sheath.The hcp removed the lutonix dcb and the introducer sheath as a single unit.The lutonix dcb's balloon reportedly tore during the retraction attempt and allegedly a piece of the balloon was missing.The hcp reportedly reviewed the patient's vasculature angiographically to determine if any vasculature damage occurred.Although requested, additional information regarding the results of the angiographic research has not yet been received.The lutonix dcb was requested to be returned for evaluation.No adverse patient outcomes were reported.

Manufacturer Narrative

Analysis/device evaluation: upon receipt of the sample, the outer shaft was separated at the hub due to a hub bond failure.The inner lumen was kinked near the strain relief and approximately 33mm from the distal end of the catheter hubs strain relief.The inner lumen between the proximal outer shaft and the catheter's strain relief was stretched.The proximal marker band shifted from its original position to approximately 53mm from the proximal balloon bond.Under magnification (10x-30x), the outer shaft appeared to be damaged in two locations, one at 50mm and the other at 55mm from the proximal bond area.The returned balloon was pulled inside itself with the inner lumen slightly accordioned.The end of the returned balloon is partially folded and torn with jagged edges.A longitudinal tear with a perpendicular tear were observed from the proximal balloon bond to the end of the returned balloon.The balloon was bunched at the distal balloon bond.The proximal and distal balloon bonds are intact.The distal marker band is shifted from its original location to the proximal balloon area.The distal tip of the catheter does not appear to be damaged.Destructive testing was performed by creating a small cut in the outer layer of the proximal balloon so the evaluator could confirm the entire length of the balloon was present.The balloon was slowly outstretched and straightened.The entire balloon is present and was measured to be 60mm.There were no missing pieces from the balloon, as reported by the hcp.A lot history review revealed this is the only complaint associated with 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 confirmed the lutonix dcb appeared to be torn during retraction.The end of the returned balloon is partially folded and torn with jagged edges.A longitudinal tear with a perpendicular tear were observed from the proximal balloon bond to the end of the returned balloon.The catheter shaft damaged areas may possibly be the result of a sharp tool used to grasp the catheter shaft during retraction.Destructive testing confirmed the entire length of the balloon was present.The entire balloon appeared to be present.The severe damage to the returned lutonix dcb hub and catheter shaft was likely due to retraction forces used by the hcp to remove the catheter from the patient through the introducer sheath.The vessel pathway contained a previously placed stent and the lesion was calcified.The dhr found nothing to indicate a manufacturing related cause for this event.The hcp reportedly assessed the patient's vascular angiographically to determine if any vasculature damage occurred.During the angiographic review, the balloon portion was not visible.No surgical attempt was performed.Furthermore, a piece of the lutonix dcb is not missing and medical or surgical intervention was not performed to prevent permanent impairment.If additional information is received, a supplement report will be submitted with all relevant information.

Event Description

It was reported after a successful treatment, the lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter's balloon allegedly tore during retraction.The health care professional (hcp) used an ipsilateral approach with a 5 french introducer sheath to gain access to the left popliteal artery.The hcp successfully advanced a predilatation balloon through the vessels stented pathway to the calcified target lesion.The target lesion was predilated.Reportedly, the lutonix dcb was advanced to the target lesion successfully and inflated to successfully treat the target lesion.After the treatment, the hcp retracted the lutonix dcb through the stented vessel pathway to the distal tip of the introducer sheath.It is unknown if balloon deflation was confirmed under fluoroscopy or if negative pressure was established prior to the attempted removal of the catheter by the hcp.Reportedly, the hcp was unable to remove the lutonix dcb through the 5 french introducer sheath.The hcp removed the lutonix dcb and the introducer sheath as a single unit.The lutonix dcb's balloon reportedly tore during the retraction attempt and allegedly a piece of the balloon was missing.The hcp reportedly reviewed the patient's vasculature angiographically to determine if any vasculature damage occurred.During the angiographic review, the balloon portion was not visible.No surgical attempt was performed.The lutonix dcb was returned for evaluation.No adverse patient outcomes were reported.

• 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: 7220911
• MDR Text Key: 98280908
• Report Number: 3006513822-2018-00011
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741123092
• UDI-Public: (01)00801741123092
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 9004
• Device Catalogue Number: 9090410600060
• Device Lot Number: GFAY0971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2018
• Supplement Dates Manufacturer Received: 02/09/2018
• Supplement Dates FDA Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 84