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 2018-12-18 for LUTONIX 035AV DRUG COATED BALLOON PTA CATHETER 9010 LX3575840V manufactured by C.r. Bard, Inc. (gfo).
[130909877]
Analysis: the sample has been requested for evaluation, but has not been received. A device history record (dhr) review was performed and noted the device was manufactured to specification prior to being released for distribution. Conclusion: the sample has been requested for evaluation, but has not been received. Upon completion of the investigation, a supplement report will be submitted with all relevant information.
Patient Sequence No: 1, Text Type: N, H10
[130909878]
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly would not deflate after successfully treating the target lesion in the cephalic av fistula. The health care professional (hcp) attempted to use an inflation device to get the lutonix balloon to collapse on itself, switched to a syringe, but neither of these attempts were successful in deflating the balloon. Finally, the hcp reportedly attempted to rupture the balloon, but in the process the av fistula allegedly ruptured. The hcp repaired the ruptured av fistula with a covered stent. Although requested, it is unknown how the lutonix dcb was removed from the patient. The lutonix dcb was requested to be returned for evaluation. No further adverse outcomes were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2018-00289 |
| MDR Report Key | 8177429 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-18 |
| Date of Report | 2019-02-04 |
| Date of Event | 2018-11-27 |
| Date Mfgr Received | 2019-01-15 |
| Device Manufacturer Date | 2017-08-28 |
| Date Added to Maude | 2018-12-18 |
| 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 | 2018-12-18 |
| Model Number | 9010 |
| Catalog Number | LX3575840V |
| Lot Number | GFBS2141 |
| Device Expiration Date | 2019-05-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2018-12-18 |