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 2019-08-26 for LUTONIX 035AV DRUG COATED PTA DILATION CATHETER 9010 LX35751060V manufactured by C.r. Bard, Inc. (gfo).
[157482511]
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 one reocclusion complaint was associated with this lot. A review of the device history record (dhr) indicates the lot was manufactured to specification. Investigation summary: the actual sample was not returned for evaluation. It is known that the patient? S target lesion was reportedly reoccluded. A revascularization was performed and the hcp deemed it was successful. The investigator assessed that the event was possibly related to the study device, but not related to the procedure. The root cause could not be determined based upon the available information received from the post market clinical registry. 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
[157482512]
It was reported through a (b)(6) study during the index procedure, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion in the left upper arm brachial cephalic. Approximately 133 days post index procedure, the target lesion was reoccluded. Re-intervention was performed with successful result. The investigator assessed the reocclusion event was possibly related to the study device and not related to the index procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2019-00112 |
| MDR Report Key | 8933079 |
| Report Source | HEALTH PROFESSIONAL,OTHER,STU |
| Date Received | 2019-08-26 |
| Date of Report | 2019-08-26 |
| Date of Event | 2019-06-28 |
| Date Mfgr Received | 2019-07-31 |
| Device Manufacturer Date | 2018-08-29 |
| Date Added to Maude | 2019-08-26 |
| 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 035AV DRUG COATED PTA DILATION CATHETER |
| Generic Name | DRUG COATED PTA BALLOON |
| Product Code | PRC |
| Date Received | 2019-08-26 |
| Model Number | 9010 |
| Catalog Number | LX35751060V |
| Lot Number | GFCU1585 |
| 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 | 2019-08-26 |