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 2018-02-28 for LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9010 LX3575760V manufactured by C.r. Bard, Inc. (gfo).
[101510081]
Analysis: the sample was discarded at the user facility; therefore, an evaluation is unable to be performed. A lot history review revealed this is the only complaint associated with this lot. A device history record (dhr) review was performed and noted the device was manufactured to specification prior to being released for distribution. There was nothing found to indicate there was a manufacturing related cause for this event. Conclusion: the actual sample was discarded b the user facility and not available for evaluation. The dhr found nothing to indicate a manufacturing related cause for this event. Reportedly, the lutonix dcb was inflated greater than nominal pressure to treat the target lesion. Allegedly, a pinhole material rupture was observed after the device was successfully removed from the patient. Although requested, patient demographics and additional event details regarding vessel morphology and device advancement techniques were unavailable. Thus, a definitive root cause could not be determined based on the information provided. It is unknown if patient and/or procedural issues contributed to the reported event. If additional information is received, a supplement report will be submitted 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
[101510082]
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly has a material rupture or pinhole, after being inflated to 12 atms (atmospheres). The rupture allegedly occurred during treatment of the target lesion in the av fistula of the cephalic vein. The health care professional (hcp) predilated the target lesion. Reportedly, the hcp fully inflated the lutonix dcb for 3 minutes to treat the target lesion. The lutonix dcb was retracted without issues and allegedly a material rupture, specifically a pinhole, was observed on the sterile table upon removal from the patient. The lutonix dcb was discarded by the user facility and is not available for evaluation. No adverse patient outcomes were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2018-00033 |
| MDR Report Key | 7304878 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-28 |
| Date of Event | 2018-01-30 |
| Device Manufacturer Date | 2017-08-28 |
| Date Added to Maude | 2018-02-28 |
| 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 | 2018-02-28 |
| Model Number | 9010 |
| Catalog Number | LX3575760V |
| Lot Number | GFBT0669 |
| 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 | 2018-02-28 |