MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-26 for LUTONIX 035AV DRUG COATED BALLOON PTA CATHETER 9010 LX35751240V manufactured by C.r. Bard, Inc. (gfo).
[131945204]
The sample was discarded at the user facility; therefore, an evaluation is unable to be performed. A lot history review revealed this is the only complaint associated with material rupture for this lot. The product identifiers were obtained; therefore, a device history record (dhr) was reviewed for this device. There was nothing found to indicate there was a manufacturing related cause for this event. The actual sample was not received for evaluation. The dhr found nothing to indicate a manufacturing related cause for this event. It was noted the target lesion region was predilated and the pathway to the treatment location was not tortuous. Allegedly, the lutonix dcb ruptured during or immediately after inflation. The hcp reportedly described the material rupture as a pinhole. The lutonix dcb was promptly and safely removed from the patient. Based on the information obtained related to the event and the investigation, a definite root cause cannot be determined. It is unknown if procedural issues contributed to the reported event. If additional information becomes available, a supplement report will be submitted with all relevant information. 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.
Patient Sequence No: 1, Text Type: N, H10
[131945265]
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured while treating the non tortuous target lesion in the brachiocephalic vein of the av fistula. The health care professional (hcp) gained patient access through the cephalic vein of the av fistula with a 9 (b)(4) cordis introducer sheath over an 035 bentson guidewire. The hcp predilated the target lesion with an atlas 12 x 40 mm percutaneous transluminal angioplasty (pta) balloon. Allegedly, the lutonix dcb ruptured during or immediately after inflation. The hcp reportedly described the material rupture as a pinhole. The lutonix dcb was promptly and safely removed from the patient. Another balloon was used to complete the procedure. The lutonix dcb was discarded by the user facility and is not available for return. No adverse patient outcomes were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2018-00294 |
| MDR Report Key | 8195878 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2018-06-18 |
| Date Added to Maude | 2018-12-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MIKE GAFFNEY |
| Manufacturer Street | 9409 SCIENCE CENTER DR |
| Manufacturer City | NEW HOPE MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7634458639 |
| Manufacturer G1 | C.R. BARD, INC. (GFO) |
| Manufacturer Street | 289 BAY ROAD |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUTONIX 035AV DRUG COATED BALLOON PTA CATHETER |
| Generic Name | DRUG COATED BALLOON PTA CATHETER |
| Product Code | PRC |
| Date Received | 2018-12-26 |
| Model Number | 9010 |
| Catalog Number | LX35751240V |
| Lot Number | GFCS1215 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (GFO) |
| Manufacturer Address | 289 BAY ROAD QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-26 |