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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION CATHETER; DRUG COATED BALLOON PTA CATHETER
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LUTONIX, INC LUTONIX 035 DRUG COATED PTA DILATATION CATHETER; DRUG COATED BALLOON PTA CATHETER Back to Search Results
Model Number 9004
Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546); Failure to Advance (2524); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2022
Event Type  malfunction  
Event Description
It was reported that during an angioplasty procedure, the device was allegedly could not be advanced in the patient.It was further reported that guidewire was stuck on the balloon and it could not be removed.Reportedly, the balloon was shrunk and broke while the wire was removed from the balloon.The procedure was completed by using another device.There was no reported patient injury.
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 02/2024).
 
Event Description
It was reported that during an angioplasty procedure, the device was allegedly could not be advanced in the patient.It was further reported that guidewire was stuck on the balloon and it could not be removed.Reportedly, the balloon was shrunk and broke while the wire was removed from the balloon.The procedure was completed by using another device.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged failure to advance guidewire, difficult to remove guidewire and break could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 02/2024), g3, h6(method).H11: section a through f - the information provided by bd 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 bd.
 
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Brand Name
LUTONIX 035 DRUG COATED PTA DILATATION CATHETER
Type of Device
DRUG COATED BALLOON PTA CATHETER
Manufacturer (Section D)
LUTONIX, INC
9409 science center dr
new hope 55428
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury 12804
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13993491
MDR Text Key288473253
Report Number3006513822-2022-00011
Device Sequence Number1
Product Code ONU
UDI-Device Identifier00801741166952
UDI-Public(01)00801741166952
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
P130024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/30/2022
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 Model Number9004
Device Catalogue Number9090413600150
Device Lot NumberGFFN0974
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/09/2022
Initial Date FDA Received04/04/2022
Supplement Dates Manufacturer Received06/01/2022
Supplement Dates FDA Received06/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
Patient Weight68 KG
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