MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other, report with the FDA on 2018-12-12 for LUTONIX 035AV DRUG COATED BALLOON PTA CATHETER 9010 LX35100860V manufactured by C.r. Bard, Inc. (gfo).
[130473819]
Analysis/preliminary evaluation: upon receipt of the sample, visual examination of the entire length of the catheter revealed a longitudinal material rupture extending from the proximal balloon bond to the middle of the balloon. Functional testing of the complaint sample concluded the longitudinal material rupture would not allow the balloon to inflate. The complaint sample was decontaminated and prepared for further evaluation. A lot history review revealed this is the only complaint associated with this lot. A review of the device history record (dhr) indicates the lot was manufactured to specification. Conclusion: the returned sample is undergoing evaluation, which has not yet been completed. The dhr found nothing to indicate a manufacturing related cause for this event. Upon completion of the investigation, a supplement report will be submitted with all relevant information.
Patient Sequence No: 1, Text Type: N, H10
[130473820]
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured while treating a non calcified target lesion located in the av fistula. The health care professional (hcp) gained access from the patient's arm with a 7 french boston scientific super sheath over an 035 bentson guidewire. Reportedly, the hcp predilated the target lesion with a 8 x 60mm mustang percutaneous transluminal angioplasty (pta) balloon. The hcp reached the target lesion with the lutonix dcb and attempted to inflate the balloon. Reportedly, on the first inflation the lutonix dcb allegedly ruptured after achieving 8 atmospheres (atms) of pressure. The procedure was completed with an additional lutonix dcb. The lutonix dcb was returned for evaluation. No adverse patient outcomes were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2018-00285 |
| MDR Report Key | 8156176 |
| Report Source | COMPANY REPRESENTATIVE,OTHER, |
| Date Received | 2018-12-12 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2019-01-08 |
| Device Manufacturer Date | 2018-04-27 |
| Date Added to Maude | 2018-12-12 |
| 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 | 2018-12-12 |
| Returned To Mfg | 2018-12-11 |
| Model Number | 9010 |
| Catalog Number | LX35100860V |
| Lot Number | GFCQ2569 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-12-12 |