MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-10-26 for LUTONIX 035 DRUG COATED BALLOON PTA CATHETER 9010 LX35751240V manufactured by C.r. Bard, Inc. (gfo).
[90324763]
Analysis/device evaluation: upon receipt of the sample, visual examination was performed which revealed the catheter's shaft was severely kinked. The kink was located approximately 114 mm from the proximal balloon bond. The catheter was returned within the procedural introducer sheath with the balloon inflated. Further inspection revealed focal necking of the outer shaft, distal to the 20 cm geomarker. The severe kink was within the area of focal necking. After decontamination, negative pressure was applied using an indeflator. The balloon deflated completely, but at an extremely slow rate. A lot history review revealed this is the only complaint associated with a deflation issue 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: returned product analysis confirmed the deflation issue of the lutonix dcb. The severe kink was within the area of focal necking on the outer shaft, distal to the 20 cm geomarker. When negative pressure was applied to remove the dilute contrast fluid, the rate of deflation was extremely slow. The hcp reportedly applied negative pressure several times, but the inflation solution was not completely removed from the balloon. The hcp allegedly began to retract the lutonix dcb from the access circuit, without completely deflating the balloon. The sequence of events related to the kinking/focal necking and subsequent retraction difficulty is unknown. 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
[90324764]
It was reported a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter allegedly would not deflate, after treatment of the av circuit outflow tract in the cephalic vein. The health care professional (hcp) gained patient access in the antecubital space through the cephalic vein with a cordis 10 french introducer sheath over a boston amplatz guidewire. The hcp reportedly predilated the target lesion with a 12 mm x 40 mm mustang balloon. Allegedly, the lutonix dcb was prepared in the normal fashion and the balloon protector was removed without issues. The hcp advanced the lutonix dcb, under negative pressure, to the target lesion successfully. The lutonix dcb was allegedly inflated to 9 atmospheres (atms), with a 75% saline/25% contrast solution, once for two minutes. Once the treatment was completed, the balloon would not deflate. The hcp reportedly applied negative pressure several times, but the inflation solution was not completely removed from the balloon. The hcp allegedly began to retract the lutonix dcb from the access circuit, without completely deflating the balloon. The hcp had difficulty retracting the balloon portion of the lutonix dcb into the cordis introducer sheath. Reportedly, the lutonix dcb and the introducer sheath were removed through a venotomy. Patient access was retained via the guidewire and the hcp allegedly made an additional treatment with another device to complete the procedure. Reportedly, the access site and venotomy were closed with purse string sutures. The lutonix dcb was returned for evaluation. No further adverse patient outcomes were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006513822-2017-00208 |
| MDR Report Key | 6979542 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-26 |
| Date of Report | 2017-10-26 |
| Date of Event | 2017-09-29 |
| Device Manufacturer Date | 2017-08-28 |
| Date Added to Maude | 2017-10-26 |
| 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 | 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 | 2017-10-26 |
| Returned To Mfg | 2017-10-09 |
| Model Number | 9010 |
| Catalog Number | LX35751240V |
| Lot Number | GFBS2140 |
| Device Expiration Date | 2019-05-16 |
| 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; 2. Required No Informationntervention | 2017-10-26 |