MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-12-18 for LUTONIX 035AV DRUG COATED BALLOON PTA CATHETER 9010 LX3575860V manufactured by C.r. Bard, Inc. (gfo).
[131804478]
Analysis/preliminary evaluation: upon receipt of the sample, visual examination was performed over the entire length of the catheter, which revealed several kinks at the distal end of the strain relief, 33 cm, 24 cm, and 21 cm geomarkers. The outer shaft had intermittent focal necking between the 21-34 cm geomarkers. Also, the outer shaft was focally necked proximal to the balloon bond. The distal inner lumen was torn at the 26 cm geomarker. Both ends of an inner lumen section, distal to the 20 cm geomarker and proximal to the 21 cm geomarker, were torn. The distal end of the outer shaft was torn. The proximal outer shaft was torn and the inner shaft was accordioned in 3 different locations proximal to the balloon bond. The separated portion of the catheter was present on the returned guidewire and could not be removed from the catheter. The balloon was still pleated/folded. Functional testing revealed neither of the two catheter ports were able to be successfully flushed. Conclusion: the returned sample is undergoing evaluation, which has not yet been completed. Upon completion of the investigation, a supplement report will be submitted with all relevant information.
Patient Sequence No: 1, Text Type: N, H10
[131804479]
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly failed to advance completely through a 7 french cordis bright tip introducer sheath and as a result the hub was detached during removal. The health care professional (hcp) gained patient access to treat the target lesion located in the radiocephalic av fistula in the patient's left forearm. The hcp predilated the target lesion and then prepped the lutonix dcb in accordance with the instructions for use (ifu). The hcp loaded the lutonix dcb onto an 035 terumo glidewire of regular stiffness and advanced the lutonix dcb. Reportedly, the lutonix dcb was unable to be advanced forward or removed from the guidewire. The hcp reportedly applied force to remove the lutonix dcb. Allegedly, the lutonix dcb? S hub then separated from the catheter shaft during an attempt to remove the lutonix dcb. Then the hcp removed the lutonix dcb and the guidewire as a single unit, while maintaining patient access with the introducer sheath. Another guidewire and lutonix dcb were used to complete the procedure without issues. The lutonix dcb was returned for evaluation, which revealed the catheter's inner lumen and outer shaft were torn in the middle. Furthermore, the distal portion of the catheter was stuck on the guidewire. No adverse patient outcomes were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2018-00288 |
| MDR Report Key | 8177412 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-12-18 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-11-12 |
| Date Mfgr Received | 2018-12-21 |
| Device Manufacturer Date | 2018-06-28 |
| Date Added to Maude | 2018-12-18 |
| 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 | MIKE GAFFNEY |
| Manufacturer Street | 9409 SCIENCE CENTER DR |
| Manufacturer City | NEW HOPE MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7634458639 |
| 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 | 2018-12-18 |
| Returned To Mfg | 2018-11-26 |
| Model Number | 9010 |
| Catalog Number | LX3575860V |
| Lot Number | GFCS3003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-12-18 |