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

Model Number 9004

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis/sample evaluation: upon receipt of the sample, visual examination of the entire length of the catheter revealed the catheter was returned without the distal half of the balloon, distal portion of the inner lumen, or the distal marker band (mb).The proximal portion of the balloon, which was returned, did not appear to be ruptured.The distal portion of the balloon along with inner lumen appears to be torn from the proximal portion of the balloon and inner lumen.The edge of the returned portion of the balloon was jagged.The remaining balloon was returned with the inner lumen and the proximal mb.The balloon appeared to have pinch marks around the middle of the balloon.The entire catheter was covered with contrast and blood residue in multiple locations.The outer shaft was gouged near 21, 22, 23 geo markers, with slight surface scratches.The inner lumen was stretched between 87-88 geomarker.A lot history review revealed this is the only complaint associated with balloon rupture for this lot.A device history record (dhr) review was performed and noted the device was manufactured to specification prior to being released for distribution.There was nothing found to indicate there was a manufacturing related cause for this event.Conclusion: returned product analysis determined the balloon likely ruptured in the distal end of the unreturned balloon, as reported by the health care professional (hcp).The returned sample revealed the balloon was torn during retraction resulting in the hcp difficulties removing the device from the patient.The catheter was returned without the distal half of the balloon, distal portion of the inner lumen, or the distal mb.The proximal portion of the balloon, which was returned, did not appear to be ruptured.The hcp stated, "as the lutonix dcb was being retracted, the distal portion of the balloon became caught in the introducer sheath." the sheath was not returned for evaluation.The hcp removed the distal end of the lutonix dcb and the introducer sheath as a single unit.The hcp alleged the lutonix dcb ruptured longitudinally at the distal end of the balloon, while inflating the device a second time to 11 atmospheres in a highly calcified lesion in the iliac artery.The hcp treated the iliac artery, which indicates the lutonix catheter was used in an 'off-label' indication.In the opinion of the hcp, the calcification in the target lesion was related to the nature of the material rupture.It is possible the reported longitudinal rupture in the distal end of the balloon was the source of the balloon being lodged at the distal end of the introducer sheath.A definitive root cause of the alleged rupture could not be determined based on the information and sample provided.Patient anatomy may have contributed to the reported event.

Event Description

It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured while inflating to 11 atmospheres (atms) in a highly calcified target lesion in the iliac artery (off-label) for a second time.The health care professional (hcp) used an ipsilateral technique to gain patient access.The hcp predilated the highly calcified target lesion with an ultraverse balloon.The hcp inflated the lutonix dcb twice, and on the second inflation to 11 atms the balloon ruptured longitudinally at the distal end of the balloon.As the lutonix dcb was being retracted from the patient, the distal end of the balloon became caught in the introducer sheath.The hub, catheter, and proximal balloon were removed from the patient.Thus, the hcp removed the distal end of the lutonix dcb and the introducer sheath as a single unit.In the opinion of the hcp the calcification in the target lesion is related to the nature of the material rupture.The sample 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
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: john risse ; 9409 science center dr; new hope, MN 55428 ; 7634632917
• MDR Report Key: 7970665
• MDR Text Key: 126096001
• Report Number: 3006513822-2018-00226
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00801741166952
• UDI-Public: (01)00801741166952
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P130024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/16/2018

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: 01/20/2021
• Device Model Number: 9004
• Device Catalogue Number: 9090413600150
• Device Lot Number: GFBZ2188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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 Age: 62 YR