MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-22 for LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9010 LX3575660V manufactured by C.r. Bard, Inc. (gfo).
[93570434]
Analysis: the sample was not released 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 released from the user facility. The dhr found nothing to indicate a manufacturing related cause for this event. Although requested, the physical sample, patient demographics, and additional event details were not available. 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
[93570435]
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly was difficult to deflate after treatment of the subclavian artery. The health care professional (hcp) predilated the target lesion prior to dcb treatment. Upon removal of the lutonix dcb through the introducer sheath, allegedly the balloon portion of the device detached from the catheter shaft. It is unclear at this time if the balloon completely detached from the catheter or if a balloon bond separated from the catheter shaft. The lutonix dcb was requested to be returned for evaluation, but at this time the facility will not release the sample to the manufacturer. Although requested, the physical sample, patient demographics, and additional event details were not available. No adverse patient outcomes were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2017-00294 |
| MDR Report Key | 7054589 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-22 |
| Date of Report | 2017-12-20 |
| Date of Event | 2017-10-26 |
| Date Mfgr Received | 2017-12-01 |
| Device Manufacturer Date | 2017-08-28 |
| Date Added to Maude | 2017-11-22 |
| 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 | 2017-11-22 |
| Model Number | 9010 |
| Catalog Number | LX3575660V |
| Lot Number | GFBS3454 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2017-11-22 |