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 2019-08-16 for LUTONIX 035 AV DRUG COATED PTA DILATION CATHETER 9010 LX35751060V manufactured by C.r. Bard, Inc. (gfo).
[154580703]
Manufacturing review: the sample was not returned from the user facility; therefore, device evaluations are unable to be performed. Lot history review revealed this is the only complaint for corporate lot number gfbt1683. A dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: the sample was not returned by the facility for further evaluation. It is known that approximately 332 days post index procedure, a fistulogram indicated the target lesion was reoccluded. An angioplasty procedure was performed and it was deemed successful. The investigator assessed the reocclusion event was not related to the study device or to the index procedure, but definitely related to the av access circuit. However, the lack of further information or the returned sample prevents both confirmation of the reported event and identification of a root cause(s). Label review: 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.
Patient Sequence No: 1, Text Type: N, H10
[154580704]
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 right upper arm basilic vein swing point. Approximately 332 days post index procedure, reportedly fistulogram indicated the target lesion was reoccluded. Angioplasty was performed with successful result. The investigator assessed the reocclusion event was not related to the study device or to the index procedure, but definitely related to the av access circuit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2019-00108 |
| MDR Report Key | 8901924 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2019-08-16 |
| Date of Report | 2019-08-16 |
| Date of Event | 2019-07-05 |
| Date Mfgr Received | 2019-07-25 |
| Device Manufacturer Date | 2017-08-28 |
| Date Added to Maude | 2019-08-16 |
| 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 | 1625 W 3RD ST. |
| 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 035 AV DRUG COATED PTA DILATION CATHETER |
| Generic Name | DRUG COATED BALLOON PTA CATHETER |
| Product Code | PRC |
| Date Received | 2019-08-16 |
| Model Number | 9010 |
| Catalog Number | LX35751060V |
| Lot Number | GFBT1683 |
| Device Expiration Date | 2019-06-15 |
| 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 | 2019-08-16 |