MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-10-28 for LUTONIX 035AV DRUG COATED PTA DILATATION CATHETER 9010 LX3575860V manufactured by Lutonix, Inc.
[169286424]
The lot number for the malfunction was provided and a lot history review was performed. The device was not returned to bd for evaluation. Images were provided by the facility and, after review, confirmed a tear in the catheter. The device is labeled for single use. The lutonix dcb is not approved for use in the aorta. Therefore, the off-label use of the device led to the patient injury that was reported. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[169286425]
It was reported that the patient was being treated for stenosis in an aortic stent and bilateral iliac stents, which was worse on the right side. Prior to the index procedure the stenosis in the aorta was predilated with a 12mm pta balloon via retrograde femoral access. The lesion in the right iliac stent and into the aortic stent was treated with a drug coated balloon. The drug coated balloon allegedly ruptured. The device was removed from the patient, however, there was detached material identified. The sheath was exchanged from a 7-fr to a 8-fr in an attempt to retrieve the detached material, but was unsuccessful. It was further reported that an additional access site in the left femoral artery retrograde access was used in an attempt to remove detached material with a snare device. The snare was also unsuccessful. The physician attempted to use an access catheter to push the detached material out through the 8-fr sheath in the right femoral artery, but was also unsuccessful. A balloon expandable stent was used and the detached material was retrieved. The healthcare provider reported that the patient was brought into recovery in a stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2019-00131 |
| MDR Report Key | 9248201 |
| Report Source | OTHER |
| Date Received | 2019-10-28 |
| Date of Report | 2019-11-25 |
| Date of Event | 2019-08-29 |
| Date Mfgr Received | 2019-11-20 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-10-28 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| 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 PTA DILATATION CATHETER |
| Generic Name | DRUG COATED BALLOON CATHETER |
| Product Code | PRC |
| Date Received | 2019-10-28 |
| Model Number | 9010 |
| Catalog Number | LX3575860V |
| Lot Number | GFCR3700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUTONIX, INC |
| Manufacturer Address | 9409 SCIENCE CENTER DR NEW HOPE MN 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-28 |