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 2018-06-05 for LUTONIX 035AV DRUG COATED BALLOON PTA CATHETER 9010 LX3575940V manufactured by C.r. Bard, Inc. (gfo).
[110181995]
Analysis: the sample has been requested to be returned to the manufacturer but has not been received; therefore, an evaluation is anticipated, but has not yet begun. A lot history review revealed this is the only complaint associated with material rupture for 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 has not been received for evaluation. There was nothing found to indicate there was a manufacturing related cause for this event. A definitive root cause for the rupture could not be determined. It is unknown if procedural issues contributed to the reported event. If additional information and/or the sample 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
[110181997]
It was reported that during an angioplasty procedure of a non-calcified common iliac artery, with a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter, allegedly the balloon ruptured before being inflated to nominal pressure. The health care professional (hcp) gained patient access through the patient's right groin with a 7 french cordis brite tip introducer sheath over an angio dynamics j-tip guidewire. The hcp predilated the target lesion with a boston scientific mustang balloon. It is unknown if the hcp applied negative pressure to the lutonix dcb prior to or during advancement to the target lesion. The hcp retracted the ruptured balloon without further complications. Another lutonix dcb was used to complete the patient's procedure. The sample will be requested to be returned for evaluation. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2018-00140 |
| MDR Report Key | 7571344 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2018-06-05 |
| Date of Report | 2018-07-23 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2017-08-28 |
| Date Added to Maude | 2018-06-05 |
| 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 035AV DRUG COATED BALLOON PTA CATHETER |
| Generic Name | DRUG COATED BALLOON PTA CATHETER |
| Product Code | PRC |
| Date Received | 2018-06-05 |
| Model Number | 9010 |
| Catalog Number | LX3575940V |
| Lot Number | GFBS3457 |
| Device Expiration Date | 2019-05-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-05 |