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 2018-10-31 for LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9010 LX3575640V manufactured by C.r. Bard, Inc. (gfo).
[125917081]
Analysis: 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 this lot. A device history record (dhr) review was performed and noted the device was manufactured to specification prior to being released for distribution. Conclusion: the actual sample was not received for evaluation. The hcp reported the lutonix dcb ruptured at nominal pressure while treating the target lesion in the av fistula. Although requested multiple times, additional event details and patient demographics are unavailable. If additional information is received, a supplement report will be submitted with all relevant information.
Patient Sequence No: 1, Text Type: N, H10
[125917082]
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured at nominal pressure while treating the target lesion in the av fistula. The health care professional (hcp) discarded the lutonix dcb and it is not available for evaluation. Although requested multiple times, additional event details and patient demographics are unavailable. No adverse patient outcomes were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2018-00244 |
| MDR Report Key | 8023835 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-31 |
| Date of Event | 2018-10-04 |
| Date Mfgr Received | 2018-10-09 |
| Device Manufacturer Date | 2018-05-23 |
| Date Added to Maude | 2018-10-31 |
| 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 | JOHN RISSE |
| Manufacturer Street | 9409 SCIENCE CENTER DR |
| Manufacturer City | NEW HOPE MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7634632917 |
| 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 035 DRUG COATED BALLOON PTA CATHETER |
| Generic Name | DRUG COATED BALLOON PTA CATHETER |
| Product Code | PRC |
| Date Received | 2018-10-31 |
| Model Number | 9010 |
| Catalog Number | LX3575640V |
| Lot Number | GFCR1922 |
| 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 | 2018-10-31 |