MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2019-03-07 for LUTONIX 035AV DRUG COATED BALLOON PTA CATHETER 9010 LX3575860V manufactured by C.r. Bard, Inc. (gfo).
[141598993]
Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed. A lot history review revealed this is the only complaint 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. Reportedly on the third inflation attempt, the balloon circumferentially ruptured treating an area outside of the in-stent target lesion. The health care professional (hcp) used the lutonix dcb once on in-stent target lesion stenosis. After treatment of the target lesion, the lutonix dcb was used another time in a different location, and ruptured at low pressure. Although requested, additional event details, patient demographics, and sample return are not available at this time. If additional information or the sample is returned to the manufacturer, a supplemental report will be provided with all relevant information.
Patient Sequence No: 1, Text Type: N, H10
[141598994]
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly ruptured circumferentially on the third inflation attempt while treating an area outside of the in-stent target lesion. The health care professional (hcp) used the lutonix dcb once on the in-stent target lesion stenosis. After treatment on the in-stent lesion, the lutonix dcb was used another time in a different location, and ruptured at low pressure. Although requested, additional event details, patient demographics, and sample return are not available at this time. The lutonix dcb was requested to be returned for evaluation. No adverse patient outcomes were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2019-00041 |
| MDR Report Key | 8400519 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-02-12 |
| Device Manufacturer Date | 2018-08-23 |
| Date Added to Maude | 2019-03-07 |
| 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 PTA DILATATION CATHETER |
| Product Code | PRC |
| Date Received | 2019-03-07 |
| Model Number | 9010 |
| Catalog Number | LX3575860V |
| Lot Number | GFCU0508 |
| 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 | 2019-03-07 |