MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-11-02 for LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9004 9090410600060 manufactured by C.r. Bard, Inc. (gfo).
[126066247]
Analysis: the samples were not returned from the user facility; therefore, device evaluations are unable to be performed. A lot history review revealed 2 additional reocclusion complaints were associated with this lot. A review of the device history record (dhr) indicates the lot was manufactured to specification. Conclusion: the actual samples were not received for evaluation. The dhr found nothing to indicate a manufacturing related cause for this event. The investigator assessed the event was not related to the study devices or procedure. , but definitely related to the av access circuit 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
[126066248]
It was reported through a clinical registry that during the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesions located in the left cephalic vein. Approximately 8 months after the index procedure, the patient? S target lesions was reportedly occluded due to decreased access blood flow. A clinically driven revascularization was performed and the health care professional (hcp) deemed it was successful. The investigator assessed the event was not related to the study devices or procedure, but definitely related to the av access circuit. The samples were discarded by the user facility and are not available for evaluation. No adverse patient effects were reported. This is one of two products involved with the reported event and the associated manufacturer? S report number is 3006513822-2018-00246.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2018-00247 |
| MDR Report Key | 8034990 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-11-02 |
| Date of Report | 2018-11-05 |
| Date of Event | 2018-09-21 |
| Date Mfgr Received | 2018-11-05 |
| Device Manufacturer Date | 2016-12-20 |
| Date Added to Maude | 2018-11-02 |
| 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 | JOHN RISSE |
| Manufacturer Street | 9409 SCIENCE CENTER DR |
| Manufacturer City | NEW HOPE MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7634632917 |
| 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 DRUG COATED BALLOON PTA CATHETER |
| Generic Name | DRUG COATED BALLOON PTA CATHETER |
| Product Code | PRC |
| Date Received | 2018-11-02 |
| Model Number | 9004 |
| Catalog Number | 9090410600060 |
| Lot Number | GFAY0971 |
| Device Expiration Date | 2019-11-30 |
| 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 | 2018-11-02 |