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 2018-05-09 for LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9010 LX3575760V manufactured by C.r. Bard, Inc. (gfo).
[108258828]
Analysis/device evaluation: upon receipt of the sample, visual examination was performed which revealed extensive damage to the balloon and catheter shaft. The outer shaft of the catheter was focally necked between the proximal marker band and the 20 cm geomarker. The outer shaft was found to be pinched at approximately 44 mm from the proximal balloon bond. Functional testing was performed which revealed a 0. 035" guidewire was advanced completely through the catheter's inner lumen while under negative pressure, but some resistance encountered while passing through the balloon area. An attempt was made to deflate the balloon, but the balloon failed to completely deflate. An attempt was made to inflate and then deflate again, but the balloon would not completely deflate. A lot history review revealed this is the only complaint associated with a deflation issue for this lot. 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: returned product analysis confirmed the lutonix dcb catheter could not be fully deflated. Evaluation of the device revealed extensive damage to the balloon and catheter shaft. The catheter was focally necked, from the proximal marker band to the 20 cm geomarker, which indicates additional force was applied by the hcp to retract the balloon. The user possibly experienced difficulty removing the balloon because inflation solution was not completely removed prior to attempting to remove the catheter. The hcp may have exerted excessive force while removing the catheter, causing focal necking of the catheter shaft. The inflation lumen constriction is due to the focal necking of the catheter shaft. As a result, the balloon was unable to deflate completely. The use environment, the preparation of the dcb for introduction into the patient, as well as the technique used to retract the lutonix dcb from the target lesion and/or the patient may have caused or contributed to the deflation issue and the associated retraction difficulty following treatment. 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
[108258829]
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly was difficult to deflate, prolonging the procedure to treat the target lesion in the basilic vein outflow track of the left arm av fistula. The health care professional (hcp) predilated the target lesion with a conquest 7 x 40 mm balloon. The hcp prepared the lutonix dcb in the normal fashion and removed the balloon protector by applying negative pressure without issues. The hcp advanced the lutonix dcb through a 6 french cordis bright tip introducer sheath over an 035 bentson guidewire to the target lesion and reportedly inflated the lutonix dcb for 2. 5 minutes at 10 atmospheres (atm). The inflation medium, 50:50 saline/contrast ratio, was administered with a presto inflation device. The hcp noted the lutonix dcb allegedly deflated "sluggishly" and after 30 seconds, the device did not fully deflate. The hcp continued providing at least 60 seconds to ensure complete deflation. Reportedly, after multiple attempts to deflate the balloon with the presto indeflator, a 10 ml. Syringe was then connected and locked to create constant negative pressure. The device was able to be completely deflated and removed through the introducer sheath. The hcp reported the catheter is not kinked or obstructed. The lutonix dcb was returned for evaluation. No adverse patient outcomes were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2018-00111 |
| MDR Report Key | 7501101 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2018-05-09 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-04-11 |
| Device Manufacturer Date | 2017-08-28 |
| Date Added to Maude | 2018-05-09 |
| 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 BALLOON PTA CATHETER |
| Product Code | PRC |
| Date Received | 2018-05-09 |
| Returned To Mfg | 2018-04-18 |
| Model Number | 9010 |
| Catalog Number | LX3575760V |
| Lot Number | GFBT0669 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Hospitalization | 2018-05-09 |