MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,stu report with the FDA on 2019-07-30 for LUTONIX 035AV DRUG COATED BALLOON PTA CATHETER 9010 LX3575860V manufactured by C.r. Bard, Inc. (gfo).
[152711532]
Manufacturing review: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed. A lot history review revealed this is the only complaint associated with this lot number. A manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: the actual sample was not returned for evaluation. It is known that the access site was bleeding due to reocclusion of the target lesion. A fistulogram and an angioplasty procedure were performed, which improved the blood flow. The procedures were deemed successful. The investigator assessed the event was possibly related to the study device, but not related to the procedure. Label review: based on the instructions for use (ifu), the occurrence of a reocclusion event or a hematoma are inherent risks of any pta procedure, and have been reported in clinical trials of drug coated balloons.
Patient Sequence No: 1, Text Type: N, H10
[152711533]
It was reported through a clinical registry that during the index procedure a lutonix drug coated balloon (dcb) catheter was used to treat the patients av fistula. Approximately 107 days post index procedure, it was reported that the access site was bleeding due to reocclusion of the target lesion. A fistulogram and an angioplasty procedure were performed, which improved the blood flow. The outcome of the event was successful and the patient has recovered. The investigator assessed the event was possibly related to the study device, but not related to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2019-00104 |
| MDR Report Key | 8843136 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2019-07-30 |
| Date of Report | 2019-07-30 |
| Date of Event | 2019-05-16 |
| Date Mfgr Received | 2019-07-03 |
| Device Manufacturer Date | 2018-08-20 |
| Date Added to Maude | 2019-07-30 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| 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 | 2019-07-30 |
| Model Number | 9010 |
| Catalog Number | LX3575860V |
| Lot Number | GFCU0506 |
| 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 | 1. Required No Informationntervention | 2019-07-30 |