MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-26 for LUTONIX 035AV DRUG COATED PTA DILATATION CATHETER 9010 LX3575660V manufactured by C.r. Bard, Inc. (gfo).
[156326653]
Manufacturing review: the sample was not returned from the user facility; therefore, device evaluations are unable to be performed. Lot history review revealed this is the only complaint reported for lot: gfcr3699. The device history record was reviewed and there was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: the sample was discarded from the user facility. It is known that the patient had several different allergies noted on their chart. The patient was exposed to heparin, tpa, contrast, and paclitaxel during the angioplasty procedure. The patient experienced anaphylaxis symptoms 5 minutes post procedure. The patient experienced hives all over the body and a swollen airway , which caused difficulty in breathing. The patient was brought to the icu and the patient was stabilized by intubation and monitoring. The patient's symptoms resolved overnight. The root cause could not be determined based upon the available information received from the filed communications. Labeling review: ifu dw5159-01 in section 8 states potential adverse events which may be associated with a peripheral balloon dilatation procedure includes: allergic reaction to drugs, excipients or contrast medium as well as shock. In section 9. 0 physician counseling information states physicians should consider the following in counseling patients about this product: discuss the risks associated with a pta procedure. Discuss the risks associated with a paclitaxel coated pta catheter. Discuss the risks/benefits issues.
Patient Sequence No: 1, Text Type: N, H10
[156326675]
It was reported that upon completion of an angioplasty procedure in a forearm fistula, the patient allegedly developed an anaphylactic reaction. The health care provided reportedly believes that paclitaxel is one of the "most likely" causes of the possible anaphylactic reaction. The patient was transported to the intensive care unit, where the reaction was resolved overnight. The patient was reportedly stable after the reaction was resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2019-00111 |
| MDR Report Key | 8933075 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-26 |
| Date of Report | 2019-08-28 |
| Date of Event | 2019-07-30 |
| Date Mfgr Received | 2019-08-27 |
| Device Manufacturer Date | 2018-06-04 |
| Date Added to Maude | 2019-08-26 |
| 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 | 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 PTA BALLOON CATHETER |
| Product Code | PRC |
| Date Received | 2019-08-26 |
| Model Number | 9010 |
| Catalog Number | LX3575660V |
| Lot Number | GFCR3699 |
| 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. Hospitalization; 2. Life Threatening; 3. Other | 2019-08-26 |