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 2019-01-30 for LUTONIX 035AV DRUG COATED BALLOON PTA CATHETER 9010 LX35751060V manufactured by C.r. Bard, Inc. (gfo).
[134491139]
Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed. A lot history review revealed there is no similar reocclusion complaints associated with this lot. A review of the device history record (dhr) indicates the lot was manufactured to specification. Conclusion: the actual sample was not returned for evaluation. The dhr found nothing to indicate a manufacturing related cause for this event. The investigator assessed both events of reocclusion were possibly related to the study device and definitely related to the av access circuit, but not related to the procedure. Based on the instructions for use (ifu), the occurrence of reocclusion is an inherent risk of any pta procedure, and has been reported in clinical trials of drug coated balloons. If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.
Patient Sequence No: 1, Text Type: N, H10
[134491140]
It was reported through a post market approval study during the index procedure, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion in the cephalic arch in the left upper arm av fistula. Approximately 3 months after the index procedure, reportedly the patient had elevated venous pressures due to reocclusion of the target lesion. A clinically driven revascularization involving a fistulogram with angioplasty was performed and the health care professional (hcp) deemed it was successful. Approximately two weeks after the reintervention, the proximal segment of the cephalic vein (not target lesion) was occluded. The hcp performed a swing down procedure and it was deemed successful. The investigator assessed both events were possibly related to the study device and definitely related to the av access circuit, but not related to the procedure. The sample was discarded by the user facility and is not available for evaluation. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2019-00010 |
| MDR Report Key | 8289546 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2019-01-30 |
| Date of Report | 2019-02-21 |
| Date of Event | 2019-01-02 |
| Date Mfgr Received | 2019-02-14 |
| Device Manufacturer Date | 2018-04-16 |
| Date Added to Maude | 2019-01-30 |
| 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 | 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 | 2019-01-30 |
| Model Number | 9010 |
| Catalog Number | LX35751060V |
| Lot Number | GFCQ0734 |
| 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 | 2019-01-30 |