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 2018-08-02 for LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9010 LX3575860V manufactured by C.r. Bard, Inc. (gfo).
[115783733]
Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed. A lot history review nor a review of the device history record (dhr) could be completed due to the unknown lot number. Conclusion: the actual sample was discarded by the user facility. The hcp used the device off-label and inflated it over rbp. The hcp did not pre-dilate the lesion as suggested in the instructions for use (ifu). Although requested, additional event details, lot number and inflation pressure, were unavailable. Thus, a definitive root cause could not be determined based on the information received, but there is procedural evidence to suggest the vessel was not prepared properly and the lutonix dcb used off-label. It is unknown if patient 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
[115783734]
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used off-label to treat a stenotic region in the patient's ureter. The hcp did not pre-dilate the ureteral stenosis before treating with the lutonix dcb. The balloon reportedly ruptured circumferentially during inflation. The rupture occurred after the balloon was inflated over rated burst pressure (rbp). The inflation pressure is specifically unknown at this time, but has been requested. The hcp used a boston scientific inflation device. The lutonix dcb was removed from the patient, but the hcp reported that a fragment of balloon material was left in the patient. The hcp used a snare to successfully retrieve the balloon fragment. The hcp exchanged the lutonix dcb for another balloon to complete the procedure. The sample was discarded by the user facility and will not be returned for evaluation. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2018-00172 |
| MDR Report Key | 7742039 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-02 |
| Date of Report | 2018-08-02 |
| Date of Event | 2018-07-06 |
| Date Added to Maude | 2018-08-02 |
| 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 PTA BALLOON |
| Product Code | PRC |
| Date Received | 2018-08-02 |
| Model Number | 9010 |
| Catalog Number | LX3575860V |
| Lot Number | UNKNOWN |
| 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 | 2018-08-02 |