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 2018-02-09 for LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9004 9020475600040 manufactured by C.r. Bard, Inc. (gfo).
[99765923]
Analysis: the sample was not returned from the user facility; therefore, a device evaluation was unable to be performed. A lot history review revealed there is no similar thrombosis 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 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 device or procedure, but definitely related to the av access circuit. Based on the instructions for use (ifu), the occurrence of thrombosis is an inherent risk of any pta procedure. Furthermore, pseudoanuersym is a potential adverse event, per the ifu. If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[99765924]
It was reported through a clinical registry that during the index procedure, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the juxta-anastomotic of the axillary vein in the av fistula of the right upper arm. Approximately 2 months after the index procedure, the patient reportedly had a thrombus within the target lesion. The hcp performed percutaneous transluminal angioplasty (pta) with a surgical revision to explore the venous anastomosis. A thrombectomy involving thrombolysis therapy was performed, but the hcp deemed this treatment to be unsuccessful. Reportedly, residual thrombi with pseudoaneurysm were present after the unsuccessful procedure. The investigator assessed that the event, thrombosis, was not related to the study device or procedure, but definitely related to the av access circuit. The sample was discarded by the user facility and is not available for evaluation. No subsequent adverse patient effects have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2018-00022 |
| MDR Report Key | 7261317 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-02-09 |
| Date of Report | 2018-04-30 |
| Date of Event | 2017-11-20 |
| Date Mfgr Received | 2018-04-06 |
| Device Manufacturer Date | 2016-05-13 |
| Date Added to Maude | 2018-02-09 |
| 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 | 2018-02-09 |
| Model Number | 9004 |
| Catalog Number | 9020475600040 |
| Lot Number | GFAR0920 |
| Device Expiration Date | 2019-04-30 |
| 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 | 2018-02-09 |