MAUDE Adverse Event Report: LUTONIX INC. LUTONIX 035 DRUG COATED BALLOON PTA CATHETER; ONU

Model Number 9004

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Difficult to Advance (2920)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 05/11/2015

Event Type  Injury  

Event Description

It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was difficult to remove through an introducer sheath.The health care professional (hcp) accessed the common femoral artery using a 6fr cook ansel introducer (45cm) with a 0.035 rosen guide wire.The patient's anatomy was calcified and tortuous in nature.The hcp pre-dilated the 100mm target lesion with an 0.035 power cross balloon (5mm).There were no issues with removal of the pre dilation catheter.The hcp elected to treat the target lesion with two lutonix dcb's.The first lutonix dcb (5x100mm) was used successfully and removed through the introducer sheath without issues.The second lutonix dcb(6x100mm) was advanced with some resistance, inflated to successfully treat the target lesion, and deflated completely under negative pressure.Allegedly, the hcp encountered resistance after 90% of the balloon entered the introducer sheath while the last 10% of the balloon "bunched up".The hcp attempted to re-advance the catheter, but was unsuccessful.Numerous attempts were made to retract the balloon into the sheath, but were unsuccessful.The introducer and the lutonix dcb were pulled back to the common femoral entry site and a surgical cutdown was performed to remove the lutonix dcb and the cook introducer sheath.The catheter and sheath were discarded by the facility.No further adverse patient effects were reported.

Manufacturer Narrative

Analysis: the device was discarded at the user facility; therefore, evaluation is not able to be performed.A review of the device history record (dhr) indicates there were no issues associated with the lots first level assemblies, material review reports, raw material testing, quality control inspections, and manufacturing process.The dhr found nothing to indicate there was a manufacturing related cause for this event.Conclusion: the device was not returned for evaluation.It is unknown if patient physiology or an adverse reaction(s) with other devices/medications from the procedure could have contributed to the event.Potential factors that could have led or contributed to the reported event have been considered.Based on the information provided by the health care professional (hcp), a definitive root cause for the reported event could not be determined.A supplemental report will be submitted if new information becomes known.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.

Manufacturer Narrative

Device code was changed from difficult to remove, to retraction problem.

• Brand Name: LUTONIX 035 DRUG COATED BALLOON PTA CATHETER
• Type of Device: ONU
• Manufacturer (Section D): LUTONIX INC.; new hope MN
• Manufacturer (Section G): C.R. BARD, INC.(GFO); 289 bay road; queensbury NY 12804 2045
• Manufacturer Contact: mike gaffney ; 9409 science center dr; new hope, MN 55428 ; 7634452364
• MDR Report Key: 4840245
• MDR Text Key: 22246541
• Report Number: 3006513822-2015-00010
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2016
• Device Model Number: 9004
• Device Catalogue Number: LX351306100
• Device Lot Number: GFYJ3011
• Other Device ID Number: (01)00801741088681(17)16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 85